MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for ACCUMESH MEDIUM AMPMED manufactured by Covidien, Formerly Us Surgical A Divison.
[29915519]
(b)(4). A review of the device history record indicates this device lot number was released meeting all release specifications at the time of manufacture. A review of complaint data reveals no trend for a device related failure for this condition. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[29915520]
According to the reporter during a laparoscopic hernia repair procedure the device ruptured within the abdomen as it was extracted from the trocar. It was also reported that operative time was delayed or increased by more than 30 minutes due to the device malfunction. A fragment fell into the cavity and surgeon was able to complete the procedure as another device was readily available.
Patient Sequence No: 1, Text Type: D, B5
[37632164]
(b)(4). Evaluation summary: post market vigilance (pmv) concurrently with engineering led an evaluation of one photograph of the device. 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 engineering review of the photograph. Engineering could not determine the cause of the damage as the device was not returned for investigation. 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 device. 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. Since the device was not returned for investigation, the file will be closed as a could not be reliably determined. 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 | 1219930-2015-00949 |
| MDR Report Key | 5178158 |
| Date Received | 2015-10-26 |
| Date of Report | 2016-01-19 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2016-01-19 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2015-10-26 |
| 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 City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUMESH MEDIUM |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2015-10-26 |
| Model Number | AMPMED |
| Catalog Number | AMPMED |
| Lot Number | N3K1401UX |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |