FDA Adverse Event
Injury
Summary report: N
ENDO-THERAPEUTICS SINGLE-USE LARGE OVAL SNARE
MDR report key: 1023406
·
Received March 31, 2008
Report
- Report Number
- 1056129-2008-00001
- Event Type
- Injury
- Date Received
- March 31, 2008
- Date of Event
- February 27, 2008
- Report Date
- March 29, 2008
- Manufacturer
- ENDO-THERAPEUTICS, INC.
- Product Code
- FDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION AND DESIGN REVIEW ATTEMPTED TO DUPLICATE/IDENTIFY ANY POTENTIAL CAUSE AND WAS UNABLE TO DETERMINE CAUSE. MANUFACTURER HAS HAD NO OTHER REPORTS OF SIMILAR EVENT.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT A BOWEL PERFORATION WAS DISCOVERED DURING POST-OPERATIVE CARE OF A COLONOSCOPY PATIENT. PHYSICIAN DID NOT BELIEVE THE DEVICE WAS DEFECTIVE, HOWEVER, ATTRIBUTED THE PENETRATION TO A SHARP TIP ON THE SNARE. THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO-THERAPEUTICS SINGLE-USE LARGE OVAL SNARE | SNARE, NON-ELECTRICAL | FDI | ENDO-THERAPEUTICS, INC. | SGO-1622L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization | STANDARD ENDOSCOPE - NO OTHER DETAILS PROVIDED| BY USER FACILITY. |