MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP 176626P manufactured by Covidien.
[22862086]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22862088]
Procedure type: lap. According to the reporter: used to hold lens -when lens was inserted trocar either split or piece broke off. The current patient status is good. Unsure if a piece broke off unable to find anything in patient. A new device was used to correct the situation. There was no unanticipated blood loss of 500cc or more. Surgery time was not delayed by more than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[25269158]
Evaluation summary: post market vigilance (pmv) 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 reported condition for this incident states that the when lens was inserted trocar either split or piece broke off. The obturator was received. The trocar assembly was received. Visual inspection of the instrument noted the cannula was cracked at the distal end and a piece was returned in a plastic bag. The radial sleeve was torn at the top and disengaged. The circular and envelope seals were intact. The dilator was inserted into each trocar with no binding or difficulty. The trocar failed an air leak test. Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged trocar and expandable sleeve. 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 not display an increased trend. 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 | 9612501-2015-00435 |
| MDR Report Key | 4934397 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-07-06 |
| Date Mfgr Received | 2015-08-28 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-23 |
| 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 | BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP |
| Generic Name | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2015-07-23 |
| Returned To Mfg | 2015-08-03 |
| Model Number | 176626P |
| Catalog Number | 176626P |
| Lot Number | J5C1759X |
| 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 | 2015-07-23 |