MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-18 for KARL STORZ 11573A manufactured by Karl Storz Gmbh & Co. Kg.
[16730360]
Allegedly, during a sialoendoscopy procedure, doctor stated scope visualization was inadequate, so he proceeded with an open procedure and removed a salivary gland that he felt he had to remove anyway. Patient condition post op was good.
Patient Sequence No: 1, Text Type: D, B5
[17043369]
The semi-rigid scope has broken light fibers resulting in inadequate visualization capability. The eyepiece is leaking, the cable is leaking at where it is attached to the scope. The image bundle as well as the light bundle were compromised by the leak.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2011-00025 |
| MDR Report Key | 2139625 |
| Report Source | 05 |
| Date Received | 2011-06-18 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-05-18 |
| Date Facility Aware | 2011-05-18 |
| Report Date | 2011-06-16 |
| Date Reported to FDA | 2011-06-16 |
| Date Reported to Mfgr | 2011-06-16 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-06-11 |
| 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 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 | SIALENDOSCOPY TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-06-18 |
| Model Number | 11573A |
| Catalog Number | 11573A |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 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 | 2011-06-18 |