MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-23 for STORZ WEAPON * 23-0338 manufactured by Karl Storz.
[163701]
A 37 year old female patient with chronic otitis media was undergoing right tympanomastoidectomy procedure when the disk portion on the small weapon broke off while the physician was using the instrument in the patient's mastoid. The physician was able to remove the disk from patient and handed the instrument off the field. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[18601740]
Additional info received from mfr on 02/23/99: the enclosed medwatch was forwarded to bausch & lomb surgical, inc. From karl storz endoscopy. It is not karl storz' device. Therefore the device was forwarded to fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 212343 |
| MDR Report Key | 212343 |
| Date Received | 1999-02-23 |
| Date of Report | 1999-02-08 |
| Date of Event | 1998-12-15 |
| Date Facility Aware | 1998-12-22 |
| Report Date | 1999-02-08 |
| Date Reported to Mfgr | 1999-02-08 |
| Date Added to Maude | 1999-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ WEAPON |
| Generic Name | EAR INSTRUMENT |
| Product Code | JYG |
| Date Received | 1999-02-23 |
| Model Number | * |
| Catalog Number | 23-0338 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 206058 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-23 |