MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT 179775P manufactured by Covidien.
[25924915]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25924916]
According to the reporter, the reducor gasket was undone and could not be used. It was in that condition upon opening the trocar. No patient involved. The device will be return for investigation.
Patient Sequence No: 1, Text Type: D, B5
[33627143]
Evaluation summary: post market vigilance (pmv) and concurrently with engineering led an evaluation of one device opened by the account. This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The dilator was not received. The trocar assembly was not received. The anchoring device was received. The seal in the anchoring device was disengaged. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Subsequently, the complaint data did display an increased trend. Replication of the reported condition was due to incorrect assembly of the spring grip. A process enhancement has been implemented. There were no adverse patient events reported as a result of the alleged event. Should new information become available, the file will be re-opened and reassessed at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00538 |
| MDR Report Key | 5063611 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-12-15 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT |
| Generic Name | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2015-09-09 |
| Returned To Mfg | 2015-10-12 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J5C1941X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-09 |