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

Model Number	HP0204E
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
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 a robotic nephron protector procedure, after opening the product, it became rough in a short time.Depending on its hardening, a fracture presented itself on this device.The product could not be used due to quick drying and breaking leading to an extended surgical time.They replaced the product to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received three units sealed with the original packaging.No damage was noted to the packaging.Visual ex amination noted each 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.The instructions for use (ifu) provides a storage instruction.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 mcdermott rd; north haven CT 06473
• MDR Report Key: 7443197
• Report Number: 1219930-2018-02122
• Device Sequence Number: 16631633
• Product Code: LMG
• UDI-Device Identifier: 10884521082533
• UDI-Public: 10884521082533
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 06/19/2018
• Device Model Number: HP0204E
• Device Catalogue Number: HP0204E
• Device Lot Number: N7F0668X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 74