MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-14 for KARL STORZ 11576 manufactured by Karl Storz Gmbh & Co. Kg.
[2068569]
Allegedly, during a saliendoscopy procedure, doctor stated scope visualization was inadequate so he aborted the procedure. Patient exhibited swelling of cheek at the end of the procedure. Doctor will reschedule.
Patient Sequence No: 1, Text Type: D, B5
[9154693]
This is a semi-rigid fiberscope and the shaft of the scope was bent causing damage to internal fibers resulting in a poor image. Doctor examined scope pre-procedure and was aware that scope was bent; doctor proceeded with case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2011-00024 |
| MDR Report Key | 2141356 |
| Report Source | 05 |
| Date Received | 2011-06-14 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-05-13 |
| Date Facility Aware | 2011-05-13 |
| Report Date | 2011-06-10 |
| Date Reported to FDA | 2011-06-10 |
| Date Reported to Mfgr | 2011-06-10 |
| Device Manufacturer Date | 2009-08-01 |
| 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 | SALIENDOSCOPY TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-06-14 |
| Model Number | 11576 |
| Catalog Number | 11576 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 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 | 2011-06-14 |