MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for KARL STORZ BOWEL GRASPER 33310C manufactured by Karl Storz.
[117309695]
A portion of the bowel grasper broke and detached during surgery. The detached portion was retrieved. There was no pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079155 |
| MDR Report Key | 7784517 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-07-03 |
| Date Added to Maude | 2018-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KARL STORZ BOWEL GRASPER |
| Generic Name | BOWEL GRASPER / LAPAROSCOPIC BOWEL GRASPER |
| Product Code | OCZ |
| Date Received | 2018-08-14 |
| Catalog Number | 33310C |
| Lot Number | MH3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-14 |