MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-25 for KARL STORZ 11574A manufactured by Karl Storz Gmbh & Co. Kg.
[19934994]
Evaluation: this scope had a bent shaft, 50% broken light fibers, and image bundle had separation from the objective lens. Condition of scope is consistent with damage caused by over-torquing. We have no other complaints involving this scope.
Patient Sequence No: 1, Text Type: N, H10
[19958555]
Allegedly, during a sialendochoplasty procedure, the scope lens cracked and he lost visuals; doctor had a backup scope, but claims it would have taken too long to sterilize, so he switched to an open procedure to complete operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2009-00013 |
| MDR Report Key | 1373217 |
| Report Source | 05,06 |
| Date Received | 2009-04-25 |
| Date of Report | 2009-04-24 |
| Date of Event | 2009-03-27 |
| Date Facility Aware | 2009-03-27 |
| Report Date | 2009-04-24 |
| Date Reported to FDA | 2009-04-24 |
| Date Reported to Mfgr | 2009-04-24 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2010-02-19 |
| 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 | MINI SIALENDOSCOPY 0 DEGREES TELESCOPE |
| Product Code | FBP |
| Date Received | 2009-04-25 |
| Model Number | 11574A |
| Catalog Number | 11574A |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| 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 | 2009-04-25 |