MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-09 for KARL STORZ 11582M manufactured by Karl Storz Gmbh & Co. Kg.
[1413629]
Allegedly, during a sialendoscopy procedure, the doctor encountered severe stenosis; two 4-wire 11582ms broke; another 6-wire basket was tried but doctor was unable to get past stenosis. He switched to an open procedure to remove stones; this added about an hour to the procedure. Doctor felt anatomical difficulties were the cause rather than failure of the instrument. Possible pt was not a good candidate for endoscopy due to size and placement of stones.
Patient Sequence No: 1, Text Type: D, B5
[8511619]
First use. Devices were disposed of after the case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00001 |
| MDR Report Key | 1586268 |
| Report Source | 06 |
| Date Received | 2010-01-09 |
| Date of Report | 2010-01-08 |
| Date of Event | 2009-12-09 |
| Date Facility Aware | 2009-12-08 |
| Report Date | 2010-01-08 |
| Date Reported to FDA | 2010-01-08 |
| Date Reported to Mfgr | 2010-01-08 |
| Date Added to Maude | 2011-04-11 |
| 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 | ESOPHAGOSCOPE |
| Product Code | EOX |
| Date Received | 2010-01-09 |
| Model Number | 11582M |
| Catalog Number | 11582M |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-01-09 |