MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN PREMIUM MULTIFIRE TA; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number	010315-
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2018
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 an open thoracoscopic lobectomy procedure when the device applied on vessel, the device was difficult/unable to open.The device would not open after clamped over the tissue.It was removed using additional tool.Surgical time was extended more than 30 minutes.The surgeon took the instrument apart in order to complete the case.There was no patient injury.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the instrument was received disassembled and damaged.The loading unit was fully applied.Four properly formed staples were received.The condition of the instrument precludes functional evaluation.The root cause of the observed condition was not identified due to the amount of damage to the received device; however, the manner in which this failure occurred could not be reliably determined with the information available.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PREMIUM MULTIFIRE TA
• Common Device Name: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7284312
• Report Number: 1219930-2018-00945
• Device Sequence Number: 1028902
• Product Code: FHM
• UDI-Device Identifier: 10884521045965
• UDI-Public: 10884521045965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K801589
• 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,Followup
• Report Date (Section B): 07/03/2018

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: 10/31/2019
• Device Model Number: 010315-
• Device Catalogue Number: 010315-
• Device Lot Number: N4K1230X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 06/18/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 06/07/2018; 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1