MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-17 for ACCUMESH MEDIUM AMPMED manufactured by Covidien, Formerly Us Surgical A Divison.
[40841436]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40841437]
The surgeon could not run the device through the trocar (12mm) it got stuck. In order to make this possible they unscrewed the top of the trocar to get a bigger opening. The device could now be inserted into the abdomen but the pressure dropped to 4 since the trocar was leaking and it was impossible to put the 'top' back since the device was still in the trocar. This resulted in a very small space inside the abdomen and it was difficult to open the device and unfold the mesh inside the abdomen. The device had to be removed and could not be used again since the mesh was detached from the device (the mesh followed the device out and was not left inside the abdomen) the surgeon completed the procedure with a different mesh and everything went well.
Patient Sequence No: 1, Text Type: D, B5
[45886655]
(b)(4). Post marketing vigilance concurrently with engineering led an evaluation of one accumesh medium 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, pmv review of complaint trends and an evaluation of the returned device. The reported condition for this incident was that the device got stuck in the trocar. The device was able to function as intended and no visible damage was noted. Device was able to open/close, articulate, lock and unlock the clips. Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions. A review of the device history record indicates this lot number was released meeting all medtronic quality release specifications at the time of manufacture. The file was concluded to be tested satisfactorily as the device was found to meet all visual and functional test specifications. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-00230 |
| MDR Report Key | 5507416 |
| Date Received | 2016-03-17 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2016-03-17 |
| 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, 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 | 2016-03-17 |
| Returned To Mfg | 2016-03-15 |
| Model Number | AMPMED |
| Catalog Number | AMPMED |
| Lot Number | N5H1051UX |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-03-17 |