MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-24 for OLYMPUS CF-1TTS2 CF-1TS2 23130 manufactured by Olympus Optical Co., Ltd..
[7063]
Although the sigmoidoscopy was successfully completed in the outpatient treatment facility, it was noted upon withdrawal of the scope that a piece of the black hood which scrrrews onto the disstal end of the scope was missing. The surgeon reinserted the scope in order to retreive the missing piece but he was unable to retreive it. The pt was taken to the hospital where they were able to retreive most of the broken hood. The pt was discharged from the hospital because the surgeon was confident that the pt would pass the remaining piece. This was later confirmed by the pt and she is doing fine. Olympus has asked that the scoope be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429304-1994-00026 |
| MDR Report Key | 14300 |
| Date Received | 1994-03-24 |
| Date of Report | 1994-03-08 |
| Date of Event | 1994-03-07 |
| Date Facility Aware | 1994-03-07 |
| Report Date | 1994-03-15 |
| Date Reported to FDA | 1994-03-15 |
| Date Reported to Mfgr | 1994-03-15 |
| Date Added to Maude | 1994-06-27 |
| 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 CF-1TTS2 |
| Generic Name | FLEXIBLE SIGMOIDOSCOPE |
| Product Code | FAM |
| Date Received | 1994-03-24 |
| Model Number | CF-1TS2 |
| Catalog Number | 23130 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 13 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14296 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | SHINJUKKU SAN-EI BLDG. 22-2, NISHI SHUNJUKU 1-CHROME SHINJUKU, TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-24 |