MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-02-09 for KARL STORZ 11605FO manufactured by Karl Storz Gmbh & Co. Kg.
[1422151]
Allegedly, during a selective fetoscopy laser photo coagulation procedure, doctor removed obturator and found that the tip was missing; through visualization, he confirmed tip was still in pt. He completed procedure. Doctor decided it would be safer to leave broken piece in pt and remove it during delivery.
Patient Sequence No: 1, Text Type: D, B5
[8440073]
The shaft is slightly bent in two places and the distal tip (8. 5mm in length) has come off. The tip is laser welded to the shaft. Manufacturer said that it is possible that weld was mechanically damaged during cleaning process causing tip to become loose. Device was returned to hospital at their request.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00002 |
| MDR Report Key | 1616560 |
| Report Source | 06 |
| Date Received | 2010-02-09 |
| Date of Report | 2010-02-05 |
| Date of Event | 2010-01-07 |
| Date Facility Aware | 2010-01-08 |
| Report Date | 2010-02-05 |
| Date Reported to FDA | 2010-02-05 |
| Date Reported to Mfgr | 2010-02-05 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2010-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MITTLESTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2010-02-09 |
| Model Number | 11605FO |
| Catalog Number | 11605FO |
| Lot Number | KH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-09 |