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

Catalog 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	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the reloads misfired.Stapling is not proper.The surgeon used suture to over sew the staple line.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent 8/25/2023.D4: batch #162c98.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 revealed that one tcr55 (a) reload was received with no apparent damage.The reload was returned fully fired.No functional test could be performed due to the condition of the reload.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: place the instrument across the tissue for transection or into the lumen to form an anastomosis.For instruments with no knife, place the instrument across the tissue to be stapled.With the alignment/locking lever in the completely opened position, join the instrument halves together by aligning from either the front, center or back of the instrument.To adjust tissue on the forks before firing, move the alignment/locking lever to the intermediate position.This allows maneuvering of the tissue while the instrument halves are joined.Close the alignment/locking lever completely when the tissue is properly in place.To fire the linear cutter, place the thumb on the firing knob and two fingers on the shoulders of the linear cutter.Fire the instrument by pushing the firing knob completely forward.Completely return the firing knob to the original ¿return knob here¿ position.Separate the instrument halves by opening the alignment/locking lever and remove the instrument.Event described could not be confirmed as the reload was received fully fired.A manufacturing record evaluation was performed for the finished device batch number 162c98, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Could you please provide more details for "the reloads misfired.Stapling is not proper?" staples were not uniform and malformed.2.Did the device staple? yes.3.If the device stapled, was the staple line complete? not 100% complete.4.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? irregular.5.Did the device cut? yes.6.If the device cut, was the cut line complete? yes.7.Were the cut line and staple lines equal? no.8.Was the device fired across a staple line? no.9.Did the reload lock out and would not work? no.10.Did the reload begin to staple and cut, but then jammed? no.Just slow on firing.11.Did the device staple, but there was no cut line? no.

• 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: 17628597
• Report Number: 3005075853-2023-06109
• Device Sequence Number: 15283481
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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 Catalogue Number: TCR55
• Device Lot Number: 834A12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown