MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ACCUMESH; MESH, SURGICAL, DEPLOYER

Model Number	AMPMED
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic ventral hernia procedure, while on abdominal cavity, the mesh bunched up when trying to deploy and the arm bent and would not expand.The surgeon ended up using stay sutures to flat, positioned and attach the mesh.Surgical time was extended for 30 minutes.There was no patient injury.

• Brand Name: ACCUMESH
• Common Device Name: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8953352
• Report Number: 1219930-2019-04981
• Device Sequence Number: 16748457
• Product Code: ORQ
• UDI-Device Identifier: 10884521171282
• UDI-Public: 10884521171282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: AMPMED
• Device Catalogue Number: AMPMED
• Device Lot Number: N7A1063UX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1