MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	HP0204E
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
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, intra-operatively, the device was broken and crunching like a toast when the surgeon roll it up around the shaft of the laparoscopic instrument.Device was still used and worked on the liver bed.It was normally smooth and flexible so after the procedure they opened another same device to check and it was the usual device that expected.No patient injury has been noted.
Additional Manufacturer Narrative
Evaluation of summary: post market vigilance (pmv) led an evaluation of two photographs of a device and a video and photograph.The visual inspection of the photographs noted that the product was implanted.The product was observed to be brittle with some breaking of the mesh.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): COVIDIEN NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7168894
• Report Number: 1219930-2018-00141
• Device Sequence Number: 19196250
• Product Code: LMG
• UDI-Device Identifier: 20884521082530
• UDI-Public: 20884521082530
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: 05/23/2018
• Device Model Number: HP0204E
• Device Catalogue Number: HP0204E
• Device Lot Number: N7E0848UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1