MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN GIA; STAPLER, SURGICAL

Model Number	GIA60MTS
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open gastrectomy procedure, when firing the last three staples, there was poor staple formation.It cannot force b-shaped.The surgeon resected and re-stapled to fix the staple line.A new cartridge staple was used with the same stapler to resolve the issue.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection of the staple cartridge noted that the loading unit was partially applied and engaged in interlock.There were staples remaining at the distal end of the cartridge channel.Microscopic inspection of the knife blade displayed no damage.The instrument was not received.Functionally, since the clinical instrument was not received, a representative instrument was used.The single use loading unit (sulu) staple pushers and interlock were reset.The sulu unloaded and loaded repeatedly without difficulty.The sulu and instrument were applied to test media with acceptable results; the knife cut completely and cleanly and the remaining staple line was properly formed.The firing knob could be advanced and retracted without any hang-ups.It was reported that there was poor staple formation.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue may occur if the firing cycle was not completed.The manufacturing records for each device are thoroughly reviewed prior to r elease to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to advance the handle completely may result in incomplete staple formation, which may compromise the integrity of the staple line.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: GIA
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19117519
• Report Number: 1219930-2024-01608
• Device Sequence Number: 7558863
• Product Code: GAG
• UDI-Device Identifier: 10884521723436
• UDI-Public: 10884521723436
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K221006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: GIA60MTS
• Device Catalogue Number: GIA60MTS
• Device Lot Number: N3C0717UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male