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

Model Number	010460
Medical Device Problem Codes	Failure to Align (2522); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic right open hemicolectomy procedure, while transecting the right colon, the tip of the instrument did not seem to be aligning properly and the staple line didn't feel correct when firing or look correct post firing.The staple line was resected and re-stapled to resolve the issue.The surgeon had to free up more bowel to redo the anastomosis extending the procedure by 45 minutes.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: no abnormalities were observed with the instrument.The clinical loading unit was received.Functionally, the loading unit was reset, reloaded with staples and loaded into the clinical instrument.The loading unit was applied to test media with proper staple formation.The pin was properly aligned.No abnormalities were observed with the instrument.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: TA PREMIUM
• 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: 8042391
• Report Number: 1219930-2018-05876
• Device Sequence Number: 16469503
• Product Code: FHM
• UDI-Device Identifier: 10884521048997
• UDI-Public: 10884521048997
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 010460
• Device Catalogue Number: 010460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention