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

Model Number	GIA8048S
Medical Device Problem Codes	Failure to Align (2522); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no abnormalities.The single-use loading unit (sulu) displayed a full complement of staples.The interlock was engaged.Microscopic inspection of the knife blade displayed no damage.Functional testing found, when the sulu was reset and loaded into the instrument, that the sulu unloaded and loaded repeatedly without difficulty.The sulu and instrument were applied to test media with acceptable results.The firing knob of the instrument retracted and advanced properly without difficulty.The knife cut completely and cleanly and the staple line was properly formed.It was reported that there was difficulty with the hinge pin alignment and that the interlock was premature.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when there is improper loading of the cartridge.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: hold the single-use loading unit (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 in place.The shipping wedge is removed after the sulu is fully loaded.The sulu will float up and down in its final 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.
Event or Problem Description
According to the reporter, in a laparoscopic right hemicolectomy, during colonic anastomosis using the two firing method, the lock cover of the knife was elevated when the product was opened, so the device could not be closed.The hinge pin could not be secured in position as usual and the white flag interlock was already engaged.Another device from another lot was used to complete the case.There was no patient injury.
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.

• 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: 19519691
• Report Number: 2647580-2024-02572
• Device Sequence Number: 18277965
• Product Code: GAG
• UDI-Device Identifier: 10884523007282
• UDI-Public: 10884523007282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Expiration Date: 02/28/2025
• Device Model Number: GIA8048S
• Device Catalogue Number: GIA8048S
• Device Lot Number: P0C1343KY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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