MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-03 for KARL STORZ 26003BA manufactured by Karl Storz Gmbh & Co. Kg.
[1763846]
Allegedly, during an appendectomy procedure, a 10mm laparoscope was used, the surgeon found scope to be foggy and "wiped" the scope on the intestine and noticed a burn on the intestine. Procedure was completed. Hospital will not release any info on post-op condition of pt.
Patient Sequence No: 1, Text Type: D, B5
[8808759]
Product was not returned for eval. Hospital put the scope back into circulation. There was no report of device malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00040 |
| MDR Report Key | 1923308 |
| Report Source | 05 |
| Date Received | 2010-12-03 |
| Date of Report | 2010-11-05 |
| Date of Event | 2010-11-01 |
| Date Facility Aware | 2010-11-05 |
| Report Date | 2010-12-03 |
| Date Reported to FDA | 2010-12-03 |
| Date Reported to Mfgr | 2010-12-03 |
| 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 | MITTELSTRASSE 8 |
| 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 | RIGID SCOPE |
| Product Code | FBP |
| Date Received | 2010-12-03 |
| Model Number | 26003BA |
| Catalog Number | 26003BA |
| Lot Number | NA |
| 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 | 2010-12-03 |