MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-07 for BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT 179775P manufactured by Covidien.
[66766364]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66766365]
According to the reporter, during a lap. Oophorectomy and salpingectomy, upon opening package, a part disengaged from the side of the trocar. Udi number is not available. The status of the patient: no problem. The procedure was completed with another device. The patient gender is not available. The patient age is not available. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
Patient Sequence No: 1, Text Type: D, B5
[69477390]
(b)(4). Post market vigilance (pmv) led an evaluation of one device. Visual examination of the trocar assembly revealed that the insufflation port was disengaged from the trocar. An inspection of the stopcock weld to the cannula body noted it to be insufficient. The root cause of this condition was an assembly error during ultrasonic welding of the stopcock and cannula body. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Manufacturing actions have been implemented to prevent recurrence of this failure. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2017-00223 |
| MDR Report Key | 6309033 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-12 |
| Date of Event | 2017-01-12 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-02-07 |
| 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 | 2017-02-07 |
| Returned To Mfg | 2017-02-09 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J6F1089X |
| 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 | 2017-02-07 |