MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-19 for * 22220053 manufactured by Karl Storz Endoscopy.
[3690620]
Patient having surgery for a cabg with endoscopic saphenous vein harvesting from both legs. The pa was using the camera and it broke. The rings of the camera broke into pieces. Attempted to recreate the camera, but not sure if all the pieces and screws were retrieved. X-rays of both legs taken were negative. What was the original intended procedure? Visualization of the saphenous vein for harvesting. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3208647 |
| MDR Report Key | 3208647 |
| Date Received | 2013-06-19 |
| Date of Report | 2013-06-18 |
| Date of Event | 2013-06-12 |
| Report Date | 2013-06-18 |
| Date Reported to FDA | 2013-06-19 |
| Date Reported to Mfgr | 2013-07-08 |
| Date Added to Maude | 2013-07-08 |
| 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 | * |
| Generic Name | CAMERA, STILL, ENDOSCOPIC |
| Product Code | FXM |
| Date Received | 2013-06-19 |
| Returned To Mfg | 2013-06-13 |
| Model Number | 22220053 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-19 |