MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-09-09 for BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT 179775P manufactured by Covidien.
[54312178]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54312179]
According to the reporter: during a laparoscopic choledocholithotomy procedure, the obturator was difficult to be passed through the reuseable cannula. This occurred during the procedure but the product was not used for patient. A new device was opened to correct the problem. No adverse events have been reported.
Patient Sequence No: 1, Text Type: D, B5
[58366758]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61424929]
Evaluation summary: post market vigilance (pmv) led an evaluation of an endoport 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 trocar, obturator and spring grip were received. The circular and envelope seals were intact. However, the cannula was not received. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. The file was concluded to be not confirmed since one part of the device was not received. 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 | 9612501-2016-00573 |
| MDR Report Key | 5939358 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-08-12 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2016-09-09 |
| 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 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 | 2016-09-09 |
| Returned To Mfg | 2016-09-15 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J6B2288X |
| 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 | 2016-09-09 |