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

Catalog Number	TX30B
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Code Available (3191)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 09/16/2019.Batch # r5974g.Additional information was requested, and the following was obtained: can you please clarify the following "staple line did not hold? surgeon had to repair/suture the staple line transanally." were unformed or malformed staples seen on the staple line? was the staple line incomplete (missing staples)? did this issue occur in the original surgical procedure? or was the patient taken back to surgery (reoperation)? if yes, on what date was the patient taken back to surgery? response received: there were unformed staples.Yes the patient did have to come back to the or for further surgery one week after the original case.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? did the patient receive any preoperative chemotherapy or radiation? is it the surgeon¿s standard routine to use 30mm for this application or were there anatomical abnormalities that led to a 30mm device being used? was the device difficult to close? was it confirmed that the tissue was lying evenly in jaws with no bunching, stretching, or uneven loading of the tissue? was the reoperation due to the issue experienced with the device? can more information be provided on the intraoperative repair? what were the indications for the reoperation? what was done during the reoperation? what is the current status of the patient? device analysis: the analysis results showed that the tx30b device arrived with no apparent damaged and with a reload loaded on the device.The reload was received fully fired.In addition, a staple was received inside the plastic bag.The staple was not properly formed.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria during testing, the device performed without any difficulties noted.Although the returned staple was found to be malformed, no conclusion could be reached as to the cause of the staple malformation.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a proctocolectomy procedure, the staple line did not hold.Surgeon had to repair/suture the staple line transanally.There was no patient injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: what were the indications for surgery? chronic ulcerative colitis.Did the patient receive any preoperative chemotherapy or radiation? no.Is it the surgeon¿s standard routine to use 30mm for this application or were there anatomical abnormalities that led to a 30mm device being used? the 30 stapler is doctor's routine stapler, there were no anatomical abnormalities.Was the device difficult to close? no.Was it confirmed that the tissue was lying evenly in jaws with no bunching, stretching, or uneven loading of the tissue? yes.Was the reoperation due to the issue experienced with the device? very possibly, yes.Can more information be provided on the intraoperative repair? since many of the staples did not form, dr.Had to hand sew the anastomosis.The anastomosis was so low in the pelvis that this repair had to be done transanally.What were the indications for the reoperation? anastomotic leak.What was done during the reoperation? closure of the rectal stump as well as creation of a diverting ileostomy.What is the current status of the patient? stable, awaiting further surgery to reverse the ileostomy.(b)(4).(b)(6) hospital (b)(4).Pdf].

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9071325
• Report Number: 3005075853-2019-22034
• Device Sequence Number: 2451652
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2023
• Device Catalogue Number: TX30B
• Device Lot Number: R40V3V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 71