MAUDE Adverse Event Report: US SURGICAL PUERTO RICO GIA; STAPLER, SURGICAL

Model Number	GIA10048S
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a small bowel resection, the surgeon pushed the black firing knob only 0.5 cm then the stapler got stuck and the surgeon could not move it either way.The surgeon then dissected the stuck tissue and another of the same stapler was used and with this new stapler the black firing knob could not be pushed at all.The surgical time was extended by more than 30 minutes due to the issue.Another device from a competitor was used to resolve the issue.
Additional Manufacturer Narrative
D10 concomitant product: gia10048s, gia10048s gia100-4.8 sgl usereloadstap (lot#p3d0335).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: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the cartridge noted that the single use loading unit was partially applied and the interlock was engaged.Partially formed staples were deployed at the proximal end; the staples were not deployed at the distal end.Microscopic inspection of the knife blade displayed damage.Functional evaluation of the instrument and loading unit was conducted by reattaching the firing knob.The sulu 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 the device was not firing completely.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if an excessive upwards force is applied to the firing knob during disassembly, or if the knob is not fully rotated to one side prior to firing, causing detachment.It was also reported that there was failure to advance the handle.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the loading unit and knife blade were applied over an obstruction or thick tissue during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: ensure to select a sulu with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Do not rotate the firing knob during firing.Rotating the knob during firing may cause damage and possible instrument malfunction.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20434738
• Report Number: 2647580-2024-04422
• Device Sequence Number: 15360280
• Product Code: GAG
• UDI-Device Identifier: 10884521033634
• UDI-Public: 10884521033634
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K221013
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: GIA10048S
• Device Catalogue Number: GIA10048S
• Device Lot Number: P3D0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/22/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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 Age: 60 YR
• Patient Sex: Male