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	11/15/2018
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 left pneumonectomy procedure, the instrument remained closed on the vein.The tissue was dissected and another stapler was applied to be able to remove the device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received fully applied with tissue locked in the jaws.Functionally; the open button was pressed and the jaws released the tissue revealing a properly formed row of staples.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 8146426
• Report Number: 1219930-2018-06572
• Device Sequence Number: 1459789
• Product Code: FHM
• UDI-Device Identifier: 10884521045965
• UDI-Public: 10884521045965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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 Model Number: 010315-
• Device Catalogue Number: 010315-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1