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

Model Number	TCR55
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 04/05/2023.Batch # unknown.Per photographic evaluation: this is an analysis of a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a blue reload from the bottom side with the swing tab in the unlocked position and two double drivers down.Based on the photo the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device lot number 758a45, and no non-conformances were identified additional information was requested, and the following was received: could you please provide more details for "reload got misfired"? did the device staple? -yes.If the device stapled, was the staple line complete? ¿ the staple line was not completed.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)?- irregular.Did the device cut? -yes.If the device cut, was the cut line complete? -yes cut line happened but didn¿t get stapled.Were the cut line and staple lines equal?-yes.Was the device fired across a staple line? ¿ no.Did the reload lock out and would not work? ¿ nothing like that.Did the reload begin to staple and cut, but then jammed? -yes.Did the device staple, but there was no cut line? ¿ no it got cut but didn¿t staple.How was the procedure completed? ¿ yes ,doctor over sutured.Could you please clarify if there were any patient consequences? ¿ as it was open procedure , no major consequence.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? ¿ no complications with patient post care.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 field as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the blue reload got misfired and didn't work.No fragments were generated.The procedure was delayed by 15-minutes and completed successfully.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/12/2023.D4: batch # 720a06.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the tcr55 reload was received with no apparent damage and with the proximal 2 drivers up without staples and the remaining drivers down with staples present.The returned reload had the swing tab in the unlocked position.The cartridge was tested for functionality with a test device and fired without any difficulties.The staple line was 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.As it is possible that the firing knob was not returned to its home position while loading the reload.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 number 720a06, 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16682472
• Report Number: 3005075853-2023-02270
• Device Sequence Number: 7226508
• Product Code: GDW
• UDI-Device Identifier: 10705036013129
• UDI-Public: 10705036013129
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Model Number: TCR55
• Device Catalogue Number: TCR55
• Device Lot Number: 758A45
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown