MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIAMAX; STAPLE, IMPLANTABLE

Model Number	GIA8038RL
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Code Available (3191)
Date of Event	10/31/2019
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 right hemicolectomy, after the device was fired at the third firing (side-to-side anastomosis), when the anastomosed site was checked, it was found to be not anastomosed successfully and the staples were not formed to be u-shape.Manual suturing was performed to recover the staple line, and on the entry hole without using device.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted no abnormalities.The loading unit was received fully applied and the interlock was engaged.Microscopic inspection of the loading unit surface noted no damage.The loading unit could be loaded into the returned instrument without difficulty.Further functional testing could not be performed since the loading unit was fully applied.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: RELIAMAX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9335201
• Report Number: 1219930-2019-06417
• Device Sequence Number: 16705283
• Product Code: GDW
• UDI-Device Identifier: 20884521168630
• UDI-Public: 20884521168630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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 Expiration Date: 01/31/2022
• Device Model Number: GIA8038RL
• Device Catalogue Number: GIA8038RL
• Device Lot Number: N9B0441Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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