MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-30 for KARL STORZ LAPRASCOPIC BOWEL GRASPER 33121 NA manufactured by Karl Storz.
[57273353]
Patient Sequence No: 1, Text Type: N, H10
[57273354]
Caregivers reported that during the patient's surgical procedure the surgeon was using a karl storz bowel grasper when one of the jaws on the device broke off inside the patient. The surgeon was immediately aware of the issue. The surgeon continued with the procedure and chose to wait until after the key parts of the procedure before ordering a x-ray and then removing the broken jaw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6020886 |
| MDR Report Key | 6020886 |
| Date Received | 2016-09-30 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-08 |
| Date Facility Aware | 2016-09-08 |
| Report Date | 2016-09-21 |
| Date Reported to FDA | 2016-09-21 |
| Date Reported to Mfgr | 2016-09-21 |
| Date Added to Maude | 2016-10-12 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KARL STORZ LAPRASCOPIC BOWEL GRASPER |
| Generic Name | LAPAROSCOPIC GRASPER |
| Product Code | PMU |
| Date Received | 2016-09-30 |
| Model Number | 33121 |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | EL SEGUNDO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-30 |