Video Colonoscope May Cause Thermal Burns to Tissue During Use
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recalled device is FDA Class II and poses a risk of thermal burns to patient tissue through a heat-related malfunction. No illnesses or injuries are reported in the source, indicating the hazard is theoretical rather than realized, placing this at the High severity level per the rubric.
Plain-English summary
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) is the subject of a nationwide FDA Class II recall. This device is used to provide visual examination and therapeutic access to the lower gastrointestinal tract during endoscopic procedures.
During use, the video colonoscope can develop excessive heat at the light guide tip. In some cases, the device's image display becomes dark or reddish, and users have observed smoke-like steam emanating from the light guide area. The excessive heat poses a risk of thermal burns to the patient's mucous membranes.
A total of 152 units have been recalled nationwide. The affected serial numbers are documented in the FDA's recall notice. Healthcare facilities and providers who have used this model should stop using affected units immediately and contact the manufacturer for replacement or repair instructions.
If a patient has been exposed to this device and experiences symptoms consistent with thermal injury to the gastrointestinal tract, such as persistent pain or bleeding, they should seek medical attention and inform their healthcare provider of the device exposure during their recent endoscopy.
The recalled product
- Product
- PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
- Manufacturer
- Pentax of America Inc
- Affected units
- 152
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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