MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH90
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.What were the indications for surgery? were there any issues experienced with the device or staple form in the initial surgical procedure? what anatomic structure was the device fired on? what device was used to create the "anatamosis"? is it the surgeon¿s standard routine to use a 90mm device or were there other anatomical challenges that led to the need for a 90mm device? how many times was the device fired? was the device difficult to close? was the device difficult to fire? where in the gap setting scale was the device fired? on which portions of the resection and anastomosis was the device fired? what device was used to create the common channel? how was the leak identified? what was done during the reoperation? was the leak confirmed from the tlh90 staple line? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.Does the surgeon believe the post-operative leak was related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? what is the current status of the patient?.
Event or Problem Description
It was reported that the doctor performed a right colectomy on a patient, using a tlh90, on (b)(6) 2019.The patient returned on (b)(6) 2019, with an anastomotic leak.The doctor operated on the patient to resolve the leak.The patient status is unknown.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what were the indications for surgery? were there any issues experienced with the device or staple form in the initial surgical procedure? what anatomic structure was the device fired on? what device was used to create the anastamosis? is it the surgeon¿s standard routine to use a 90mm device or were there other anatomical challenges that led to the need for a 90mm device? how many times was the device fired? was the device difficult to close? was the device difficult to fire? where in the gap setting scale was the device fired? on which portions of the resection and anastomosis was the device fired? what device was used to create the common channel? how was the leak identified? what was done during the reoperation? was the leak confirmed from the tlh90 staple line? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.Does the surgeon believe the post-operative leak was related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? what is the current status of the patient? response: i was given this information from a first assist that helped perform the procedure the following week after the patient was brought back for a leak.She informed me that the case went well and the device worked well.She informed me that they performed a leak test during the procedure and no leaks were present.We no longer offer the device that they used and it was a device that the account had in stock.There was no device available to send back.That is all of the information that i was given.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9180421
• Report Number: 3005075853-2019-22715
• Device Sequence Number: 16908606
• Product Code: GDW
• UDI-Device Identifier: 10705036013242
• UDI-Public: 10705036013242
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: TLH90
• Device Lot Number: N92A5Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention