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

Model Number	TCR55
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open colectomy, it was found that the staples were protruded before use.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date.Batch # 348a55.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 tcr75 cartridge was received with no apparent damage and with no instrument.The swing tab was found to be in the unlocked position, unfired and with one missing staple along the cartridge deck.The reload was tested for functionality with a test device and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples meet the staple form release criteria.In addition a tyvek was received along with the device.It is possible that improper handling of the reload caused the staple to fell out, the proper handling instructions should be used when removing and reloading cartridges into the device, please reference the instructions for use.It should be noted that 100% inspection is performed by means of an automated vision system to ensure staples presence; the swing tab is present and unlocked.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, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13399435
• Report Number: 3005075853-2022-00585
• Device Sequence Number: 20003012
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: 06/30/2026
• Device Model Number: TCR55
• Device Catalogue Number: TCR55
• Device Lot Number: 344A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown