MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GST BLACK RELOAD, 45MM, 6 ROW; STAPLE, IMPLANTABLE

Catalog Number	GST45T
Medical Device Problem Codes	Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/29/2024.D4: batch # unk.B3: event day and month unknown.Captured as 1/1/24.D4: udi: as the lot number for the device involved in the event was not provided, and the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the damage occur right out of the packaging, during loading/unloading, or in the operative field? was the plastic portion of the cartridge damaged? was the metal cartridge pan separated from the plastic portion of the cartridge? what part broke (closing trigger, firing trigger, handle, jaws, buttons, etc.)? did any piece break off of the device? if yes: did it fall into the patient? did retrieval alter the procedure in any way? if yes, please explain.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
After 3 reload applied, the surgeon found the fragment which may come from reload in the patient body.So, they pick the fragment up.No patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent : 11/15/2024 corrected data: b1, h1 additional information was requested, and the following was obtained: 1.Did the damage occur right out of the packaging, during loading/unloading, or in the operative field? not sure.Surgeon noticed the plastic portion after they fired.When surgeon rinsed the operative field, they found the portion and removed it.2.Was the plastic portion of the cartridge damaged? no.Just found the plastic portion, but not caused cartridge damaged.3.Was the metal cartridge pan separated from the plastic portion of the cartridge? no.The cartridge is intact.1.What part broke (closing trigger, firing trigger, handle, jaws, buttons, etc.)? did any piece break off of the device? no.They didn¿t notice any part broke.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: GST BLACK RELOAD, 45MM, 6 ROW
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20559998
• Report Number: 3005075853-2024-08190
• Device Sequence Number: 11535261
• Product Code: GDW
• UDI-Device Identifier: 10705036014911
• UDI-Public: 10705036014911
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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 Catalogue Number: GST45T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown