MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOAD- CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CR40G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an abdominoperineal resection the staple line was opened after firing.
Additional Manufacturer Narrative
(b)(4).Date sent 2/6/2025.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: were there any patient consequences? if yes, please describe.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/24/2025.Additional information was requested, and the following was obtained: were there any patient consequences? if yes, please describe.No.
Additional Manufacturer Narrative
(b)(4).Date sent 3/7/2025, the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 3/13/2025.D4 batch #207d39.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that the cr40g reload was received with no apparent damage.The reload was received void of staples, with the washer completely cut, drivers exposed, and the knife recess below the cartridge deck.Due to the condition of the reload no functional test was performed.The event described could not be confirmed as the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: before firing, verify that the intended tissue is in the closed jaws of the instrument.If the pin is not properly positioned, staples may not form properly, which may result in leakage or disruption of the staple line.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 207d39, and no non-conformances were identified.

• Brand Name: RELOAD- CURVED CUTTER STAPLER
• 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21326604
• Report Number: 3005075853-2025-01037
• Device Sequence Number: 15433335
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: (01)10705036001430(17)290731(10)225D61
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2025

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 Catalogue Number: CR40G
• Device Lot Number: 225D61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 03/06/2025; 03/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/24/2025; 03/07/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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