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

Model Number	HP0204E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre operatively, the device broke in the middle when folded against the shaft of the instrument to bring it into the abdominal cavity.The patient status is alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information: during a gastric sleeve resection, the device broke in the middle.The doctor used floseal in order to complete the procedure.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device for evaluation.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a gastric sleeve resection, the device broke in the middle when folded against the shaft of the instrument to bring it into the abdominal cavity.The doctor used flowseal in order to complete the procedure.The patient status is alive with no injury.

• 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: 6947588
• Report Number: 1219930-2017-07962
• Device Sequence Number: 10949011
• 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,Followup
• Report Date (Section B): 12/04/2018

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: 10/12/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 09/25/2017; 11/12/2018
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 10/23/2017; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR