MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-18 for KARL STORZ 20045001-EN SAME manufactured by Karl Storz Gmbh & Co. Kg.
[18250495]
Allegedly, the doctor was performing a hysteroscopy with polyp removal when the light on the unit turned off. Hospital staff trouble shot the unit for some time before getting the light to come on. The doctor completed the procedure with no adverse impact on pt. The contact stated that troubleshooting added 45 mins to the procedure. Please refer mfr report # 9610617-2013-00025.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010202439-2013-00025 |
| MDR Report Key | 3199028 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-06-16 |
| Date of Event | 2013-05-10 |
| Date Facility Aware | 2013-05-16 |
| Report Date | 2013-06-16 |
| Date Reported to FDA | 2013-06-10 |
| Date Reported to Mfgr | 2013-06-10 |
| Date Added to Maude | 2013-07-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902450000 |
| Manufacturer Country | US |
| Manufacturer Postal | 902450000 |
| Manufacturer G1 | KARL STORZ ENDOSCOPYAMERICA INC. |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 90245000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90245 0000 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | TELE PACK X |
| Product Code | FBP |
| Date Received | 2013-06-18 |
| Returned To Mfg | 2013-06-10 |
| Model Number | 20045001-EN |
| Catalog Number | SAME |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-06-18 |