MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-18 for JAW INSERT F/CLASSIC BIP TUBAL FCP45CM MF981 manufactured by Superior Surgical Lls.
[5615252]
During tubal ligation the kleppinger did not cauterize properly and took longer to complete procedure. No patient injury. Surgery was delayed fifteen to thirty (15-30) minutes. Handle and generator in use were wolf brand products.
Patient Sequence No: 1, Text Type: D, B5
[13061148]
510k/pma: pre-amendment. Manufacturing site evaluation: evaluation is on-going.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00230 |
| MDR Report Key | 4632151 |
| Report Source | 07 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-02-17 |
| Date Added to Maude | 2015-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZLEWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | SUPERIOR SURGICAL LLC |
| Manufacturer Street | 3277 WEST RIDGE PIKE |
| Manufacturer City | POTTSTOWN PA 19464 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19464 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAW INSERT F/CLASSIC BIP TUBAL FCP45CM |
| Generic Name | BIPOLAR FORCEP |
| Product Code | HFB |
| Date Received | 2015-03-18 |
| Model Number | MF981 |
| Catalog Number | MF981 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SUPERIOR SURGICAL LLS |
| Manufacturer Address | POTTSTOWN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-18 |