MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for CLICKLINE FENESTRATED GRASP FORCEPS 33310ON manufactured by Karl Storz Endoscopy - America, Inc..
[106721116]
During a laparoscopic right inguinal hernia repair, the bowel grasper tip broke inside of the abdomen of the pt. The tip of the grasper was visualized by the surgeon and removed. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076764 |
| MDR Report Key | 7464310 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-02-08 |
| Date Added to Maude | 2018-04-26 |
| 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 | CLICKLINE FENESTRATED GRASP FORCEPS |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC |
| Product Code | NON |
| Date Received | 2018-04-25 |
| Catalog Number | 33310ON |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA, INC. |
| Manufacturer Address | EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-25 |