MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*45 ENDO LIN CUT RELOAD WH; STAPLE, IMPLANTABLE

Model Number	TR45W
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was obtained: was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? malformed staples leading to bleeding.How was the bleeding controlled? spot coagulation.How much blood was lost (ml)? not informed.Did the patient require a transfusion? not informed.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) not informed.
Event or Problem Description
It was reported that the reload did not get fired, staple formation did not happen leading to bleeding.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/22/2021; d4: batch # p55u1u.H6: component code =g04.Investigation summary: the analysis results found that one tr45w reload was received with no apparent damaged and partially fired 1/3 and with the reload lock out damaged.No functional test could be performed due to the condition of the reload.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.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 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.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12018229
• Report Number: 3005075853-2021-03394
• Device Sequence Number: 16487749
• Product Code: GDW
• UDI-Device Identifier: 10705036003182
• UDI-Public: 10705036003182
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 03/05/2022
• Device Model Number: TR45W
• Device Catalogue Number: TR45W
• Device Lot Number: P4T13W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown