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

Catalog Number	6R45B
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ent pharyngeal pouch the [patient has perforated esophagus.
Additional Manufacturer Narrative
(b)(4).Date sent 11/19/2024.D4 batch #331a05.B3: exact date is unk.Assumed first day of the month.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the return reload.Visual analysis of the returned sample determined that the one 6r45b reload was received with no apparent damage and partially fired 1/10 and with the reload lock out damaged.No functional test could be performed due to the condition of the reload.The event reported was confirmed and it is related to improper use of the reload.The damage to the reload lockout spring is consistent with damage observed when the firing cycle is started, interrupted, released, and restarted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If the re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.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 331a05, and no non-conformances related to the reported complaint condition were identified.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.

• 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 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20723766
• Report Number: 3005075853-2024-08767
• Device Sequence Number: 20472020
• Product Code: GDW
• UDI-Device Identifier: 10705036000846
• UDI-Public: (01)10705036000846(17)260731(10)402A24(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 07/31/2026
• Device Catalogue Number: 6R45B
• Device Lot Number: 402A24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6R45B
• Patient Sex: Unknown