PENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall
Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.
What this means for you
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: This is a Class II recall with documented thermal injury risk to patient tissues; no injuries or deaths have been reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) score.
Plain-English summary
Pentax of America Inc is recalling 138 PENTAX Medical Video Upper GI Scope units (Model EG29-i20c) distributed nationwide due to a thermal injury hazard.
During endoscopic procedures using the video processor EPK-i8020c with the i20c series video endoscope, the light guide at the endoscope tip becomes excessively hot during use or after removal from the patient. Users have observed smoke-like steam. The elevated temperature may cause thermal burns to patient mucous membranes. The video image can also become reddish or dark during procedures, observed in approximately 1.8% of cases.
Healthcare facilities should contact Pentax of America Inc or refer to the FDA recall notice to identify affected units by serial number. Patients who have undergone procedures with these endoscopes should consult their healthcare provider if they experience unexplained throat, esophageal pain, or burning sensations.
The recalled product
- Product
- PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
- Manufacturer
- Pentax of America Inc
- Hazard
- burn-injury
- vision-impairment
Distribution
Distributed nationwide across the United States.
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