MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-10-30 for KARL STORZ ENDOSCOPY * 27076A manufactured by Karl Storz Endoscopy.
[705307]
A holmium laser lithotripsy of a large bladder stone was attempted on patient. A large size lithotrite was inserted into bladder. While trying to trap the stone, the two end pieces of the lithotrite went in opposite directions. The instrument could not be removed. The patient was taken to surgery. The bladder was opened and the instrument and stone removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 938056 |
| MDR Report Key | 938056 |
| Report Source | 99 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-10-24 |
| Date Facility Aware | 2007-10-24 |
| Report Date | 2007-10-29 |
| Date Reported to FDA | 2007-10-29 |
| Date Reported to Mfgr | 2007-10-29 |
| Date Added to Maude | 2007-11-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ ENDOSCOPY |
| Generic Name | LITHOTRITE |
| Product Code | FGK |
| Date Received | 2007-10-30 |
| Model Number | * |
| Catalog Number | 27076A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911239 |
| Manufacturer | KARL STORZ ENDOSCOPY |
| Manufacturer Address | 600 CORPORATE POINT CULVER CITY CA 90230 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-30 |