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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2021.Batch # unknown.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.  additional information was requested, and the following was received: could you please provide more details for "misfired"?- staple pins opened.Did the device staple? incomplete staple.If the device stapled, was the staple line complete? no.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? irregular/ straight legs.Did the device cut? yes.If the device cut, was the cut line complete? yes.Were the cut line and staple lines equal? no.Was the device fired across a staple line? no.Please provide details as to how the reload did not work.¿ staple pins were malformed.Did the reload lock out and would not work?- na.Did the reload begin to staple and cut, but then jammed?- no.Did the device staple, but there was no cut line? no.If the device cut and stapled, were there any staples missing from the staple line? yes, open staple pins.How was the procedure completed? sutured.Could you please clarify if there were any patient consequences? unknown.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? no.
Event or Problem Description
It was reported that during a right hemicolectomy, cartridge misfired.The surgery was delayed by 15-minutes.Removed and replaced cartridge.Fragments were generated but removed without additional intervention.The procedure was successfully completed.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12259592
• Report Number: 3005075853-2021-04329
• Device Sequence Number: 11716764
• Product Code: GDW
• UDI-Device Identifier: 10705036013129
• UDI-Public: 10705036013129
• 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: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 12/31/2024
• Device Model Number: TCR55
• Device Catalogue Number: TCR55
• Device Lot Number: U40175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1