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

Catalog Number	CR40G
Medical Device Problem Codes	Failure to Form Staple (2579); Difficult to Open or Close (2921); Insufficient Device Problem Information (3190); Firing Problem (4011)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lar case using contour gun they opened a new gun cs40g and a new reload cr40g.Loaded it properly as per sop.When they tried firing it was very hard to fire and had an difficult time closing.Once firing audible sound heard the staples on the lower jaw of the reload misfired and damaged the tissue of colon.It was a nightmare that new cr40g misfired and no staples were not formed due to misfire.The doctor had to hand sew anastomosis which took 2 hrs.There was a 2 hour delay in surgery.The procedure was successfully completed.There were no patient consequences.Anastomosis was done properly so patient doing fine.,.
Additional Manufacturer Narrative
(b)(4).Date sent 8/8/2024.D4 batch #710c21.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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 batch.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: 9/9/2024.D4: batch #525c85.Investigation summary : the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one cr40g reload was received with the knife partially advanced, void of the staples with the washer, pin and anvil detached and not returned for analysis; no functional test was performed due to the condition of the reload.No damage on the knife was noted.The event reported was confirmed and it is related to improper use of the device.It should be noted that to reload the device insert the new reload into the metal housing and snap it into position.The tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated.Remove the staple retainer.Check that the reload is held firmly within the jaws.If the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.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 525c85, 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: 19942296
• Report Number: 3005075853-2024-05828
• Device Sequence Number: 17375701
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: (01)10705036001430(17)280630(10)710C21
• 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
• Report Date (Section B): 09/09/2024

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: CR40G
• Device Lot Number: 710C21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Unknown