MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-19 for KARL STORZ ULTRASONIC PROBE 27085LK NA manufactured by Karl Storz-endoscopy-america.
[25862]
Ultrasonic probe tip broke off during procedure and was not retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1996-00013 |
| MDR Report Key | 34888 |
| Date Received | 1996-06-19 |
| Date of Report | 1996-06-17 |
| Date of Event | 1996-05-24 |
| Date Facility Aware | 1996-06-04 |
| Report Date | 1996-06-19 |
| Date Reported to Mfgr | 1996-06-17 |
| Date Added to Maude | 1996-08-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | KARL STORZ ULTRASONIC PROBE |
| Generic Name | ULTRASONIC PROBE |
| Product Code | FGM |
| Date Received | 1996-06-19 |
| Model Number | 27085LK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36277 |
| Manufacturer | KARL STORZ-ENDOSCOPY-AMERICA |
| Manufacturer Address | 600 CORPORATE POINTE CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-06-19 |