FDA Adverse Event
Injury
Summary report: N
UNKNOWN_ENDOSCOPY_PRODUCT
MDR report key: 5717341
·
Received June 10, 2016
Report
- Report Number
- 0002936485-2016-00544
- Event Type
- Injury
- Date Received
- June 10, 2016
- Date of Event
- February 2, 2016
- Report Date
- May 17, 2016
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Additional Manufacturer Narrative · 1
THE DEVICE IS UNKNOWN AND WAS NOT RETURNED TO STRYKER ENDOSCOPY, THEREFORE ADDITIONAL INFORMATION COULD NOT BE PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION ON THE CAUTERY CORD BROKE WHICH LEAD TO SUPERFICIAL SKIN BURN DURING USE. PATIENT SUSTAINED A BURN IN THE RIGHT UPPER QUADRANT DURING A CHOLECYSTECTOMY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION ON THE CAUTERY CORD BROKE WHICH LEAD TO SUPERFICIAL SKIN BURN DURING USE. PATIENT SUSTAINED A BURN IN THE RIGHT UPPER QUADRANT DURING A CHOLECYSTECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 372633 | UNKNOWN_ENDOSCOPY_PRODUCT | UNKNOWN | GCJ | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |