MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*CUTTER VASCULAR 55MM; STAPLE, IMPLANTABLE

Model Number	TVC55
Medical Device Problem Code	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).Batch # u5c768.Date of event unknown.(b)(4).Investigation summary: 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 tvc55 device was received with no apparent damaged and with a reload loaded in the device.The reload was received with the knife not completely within doghouse and with several unformed staples on the deck, it had the proximal 17 drivers up without staples, and the remaining drivers down with staples present.The returned reload had the swing tab in the locked position.The reload was reset and the staples on the deck were removed for functional test, the device was tested for functionality with the returned 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.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that product failure is multifactorial.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.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.
Event or Problem Description
It was reported that during hemorrhoidectomy the device blocked intraoperatively and did not trigger.An additional device was opened and the op ended with no influence on surgery and pat.Safety.

• 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: 12815625
• Report Number: 3005075853-2021-06942
• Device Sequence Number: 14647016
• Product Code: GDW
• UDI-Device Identifier: 10705036013389
• UDI-Public: 10705036013389
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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 Model Number: TVC55
• Device Catalogue Number: TVC55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown