MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for OLYMPUS SD-9U 54258S manufactured by Olympus Optical Co., Ltd..
[16141]
While performing a colonoscopy, the snare broke and sprang open touching the wall of the colon. The current was still turned on when the snare touched the colon wall, and thereby caused a peerforation. The pt was taken to surgery tohave the perforation repaired, and is reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429304-1994-01532 |
| MDR Report Key | 22486 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-11-14 |
| Date of Event | 1994-11-11 |
| Date Facility Aware | 1994-11-14 |
| Report Date | 1994-11-23 |
| Date Reported to FDA | 1994-11-23 |
| Date Reported to Mfgr | 1994-11-23 |
| Date Added to Maude | 1995-06-15 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS SD-9U |
| Generic Name | REUSABLE SNARE |
| Product Code | FDJ |
| Date Received | 1995-01-18 |
| Model Number | SD-9U |
| Catalog Number | 54258S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22665 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | SHINJUKU SAN-EI BUILDING 22-2, NISHI SHINJUKU 1 CHOME SHINJUKU, TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-18 |