MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*CUTTER RELOAD UNIT; STAPLE, IMPLANTABLE

Model Number	TCR10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the open hepatectomy surgery, after installed reload closed the jaw, but could not open the jaw anymore.Another device was used to complete the procedure.There were no adverse consequences to the patient.No additional information could be provided.
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.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.Could you please provide more details how device was opened/removed? was there a change in the procedure? if yes, please explain.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 01/24/2022.Additional information was requested, and the following was received: 1.Could you please provide more details how device was opened/removed? 2.Was there a change in the procedure? response: all answers above are unobtainable.
Additional Manufacturer Narrative
(b)(4) date sent: 03/01/2022 d4: batch # u5er8w device analysis: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the tlc10 device was received with no apparent damaged and with a tcr10 reload not loaded in the device.The reload had the proximal 6 drivers up without staples, and the remaining drivers down with staples present.The swing tab was in the locked position and the fork from the right side was noted to be broken off, making the reload nonfunctionally.Further analysis shows the broken fork piece was installed in the channel; this part was removed.The device was tested for functionality with the test reload and it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.The damage on the reload has consisted of an improper loading technique.Please reference the instruction for use for proper cartridge loading.The driver's up is related to improper use of the device.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.In addition, failure to complete the stroke may result in incomplete 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, and no non-conformances were identified.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13002099
• Report Number: 3005075853-2021-07690
• Device Sequence Number: 11816408
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: 10705036003045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 11/30/2025
• Device Model Number: TCR10
• Device Catalogue Number: TCR10
• Device Lot Number: U40T8F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 12/31/2021; 02/01/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/24/2022; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown