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

Catalog Number	TCT55
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event?.
Event or Problem Description
It was reported that during an ileostomy reversal the device was cutting but not stapling.They had to cut more of the anastomis.Case completed with another device of the same product code.
Additional Manufacturer Narrative
(b)(4).Batch # r5745m.Device evaluation: the analysis results found that the tct55 device was received with no apparent damage, with no reload present.The device was tested for functionality with a test reload and it fired, cut and formed all the staples as intended.The device fired and cut without any difficulties, the staple line was complete, the cut line was complete and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7851927
• Report Number: 3005075853-2018-12522
• Device Sequence Number: 16635852
• Product Code: GDW
• UDI-Device Identifier: 20705036013140
• UDI-Public: 20705036013140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: TCT55
• Device Lot Number: R4058P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1