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

Model Number	GIA8048S
Medical Device Problem Codes	Failure to Fire (2610); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, during a partial resection of the colon descendens, the surgeon positioned the instrument on the tissue, and wanted to start firing, but unable to.Some staples were pushed, but the pusher could not be moved forward or backward anymore.The lead surgeon asked the assistant surgeon to fire the device, but the device still could not be fired.A completely new open pre-loaded stapler was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the sulu (single use loading unit) was reset and loaded into the instrument, it was unloaded and loaded repeatedly without difficulty.The sulu and instrument were applied to test media with acceptable results.The firing knob advanced and retracted without difficulty.The knife cut completely and cleanly.The remaining staples deployed and formed properly.It was reported that the instrument did not fire and staple was pre fired.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.If the firing knob is not fully retracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.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: the ifu states that to remove the sulu, separate the instrument halves.Holding the cartridge-half of the instrument, grasp the proximal end of the sulu tabs and pull up and out to remove the sulu from the instrument.To place a new sulu into the instrument, hold the sulu by the proximal end tabs and insert into the cartridge fork at a 30 to 45 degree angle from the distal end down until the unit snaps into place.Remove shipping wedge after sulu is fully loaded.Sulu will float up and down in final loaded position.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: 19729905
• Report Number: 2647580-2024-03056
• Device Sequence Number: 12844158
• Product Code: GAG
• UDI-Device Identifier: 10884523007282
• UDI-Public: 10884523007282
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: GIA8048S
• Device Catalogue Number: GIA8048S
• Device Lot Number: P3G0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: Female