MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-03 for KARL STORZ 27069K manufactured by Karl Storz Gmbh And Co. Kg.
[3697216]
During process of retrieval the doctor inadvertently drove the piece further into the prostrate and after attempts to retrieve it were successful, the doctor decided to let the piece remain in the patient. Procedure was completed and patient condition post-op was good. To our knowledge, there are no plans to schedule another procedure to remove. Ref: mfr # 9610617-2013-00027.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010202439-2013-00027 |
| MDR Report Key | 3217718 |
| Report Source | 99 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-07-03 |
| Date of Event | 2013-05-07 |
| Date Facility Aware | 2013-06-12 |
| Report Date | 2013-07-03 |
| Date Reported to FDA | 2013-07-03 |
| Date Reported to Mfgr | 2013-07-03 |
| Date Added to Maude | 2013-07-11 |
| 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 | 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 |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2013-07-03 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH AND CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-03 |