MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOADS FOR LINEAR CUTTERS; STAPLE, IMPLANTABLE

Catalog Number	6R45B
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "staple load misfired in the patient, not all staples ejected properly.Able to safely remove staple load from the patient.Surgeon did not indicate any complications." there was no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/21/2024.D4: batch # bmiptu03.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.Additional information was requested, and the following was obtained: was the firing sequence started but not completed? if yes: yes.Did the device deliver any staples? yes, partial fire.If yes, were the staples formed properly? no.If yes, was the staple line complete? no.Did the device cut? no.If yes, was the cut line complete? if yes, was there any issue with the cut line? was there any difficulty opening the device jaws? yes, rigid.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.

• Brand Name: RELOADS FOR LINEAR CUTTERS
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20496732
• Report Number: 3005075853-2024-07912
• Device Sequence Number: 14477159
• Product Code: GDW
• UDI-Device Identifier: 10705036000846
• UDI-Public: 10705036000846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 6R45B
• Device Lot Number: BMIPTU03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/21/2024
• 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