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

Model Number	HP0204E
Medical Device Problem Codes	Break (1069); Torn Material (3024); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
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: occurred prior to a laparoscopic sleeve gastrectomy procedure.When the product was folded against the shaft of the instrument to bring into the abdomen cavity, it broke in the middle.It sounded like crunching a toast.This occurred prior to being inserted into the abdominal cavity.No pieces were able to be properly implanted.The patient outcome is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: visual inspection of the returned product noted the patch was fragmented.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an investigation of this condition identified the potential root cause as a combination of a manufacturing and shipping container issue.The manufacturing process has been adjusted to prevent this condition from recurring.The use of the shipping container that contributed to the reported condition has also been discontinued.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 LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6990792
• Report Number: 1219930-2017-08403
• Device Sequence Number: 13575214
• Product Code: LMG
• UDI-Device Identifier: 10884521082533
• UDI-Public: 10884521082533
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/15/2018

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: 01/24/2018
• Device Model Number: HP0204E
• Device Catalogue Number: HP0204E
• Device Lot Number: N7A0802UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1