MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for V MUELLER LA2036 manufactured by Vmu.
[102516038]
During laparoscopic bso, the babcock lap clamp was unable to be released from the trochar resulting in the procedure being a laparotomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7338117 |
| MDR Report Key | 7338117 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-03-03 |
| Date Facility Aware | 2018-03-07 |
| Report Date | 2018-03-08 |
| Date Added to Maude | 2018-03-14 |
| 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 | V MUELLER LA2036 |
| Generic Name | 10MM BABCOCK FORCEP |
| Product Code | GEN |
| Date Received | 2018-03-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VMU |
| Manufacturer Address | 25146 NETWORK PLACE CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |