MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 34CM SHAFT; STAPLE, IMPLANTABLE

Model Number PSE45A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); No Code Available (3191)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was obtained: what were the indications for surgery? gastric bypass surgery was buttressing material used? ----no were there any difficulties with device during initial procedure to include staple formation issues? ------no was a leak test performed? if so, what were the results? after second fired, check the staple line was good.Where was the site of the leak?-----mid part of staple line which was fired on the second time.How was the gj anastomosis created? - not available how was the jj anastomosis created? -- not available what was the appearance of staple line during reoperation? leak on the mid part what is the current patient status? -- discharged from the hospital.

Event Description

It was reported that during the gastric bypass surgery, did not observe any abnormal situation in the operation and staple line was good.But three days after surgery, the patient had abdominal pain, then the surgeon did 2nd surgery, noted that anastomotic site was leakage.The surgeon used suture to oversew.The patient's condition is currently stable.

• Brand Name: PWRD ECH FLEX 45MM 34CM SHAFT
• Type of Device: 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 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10194769
• MDR Text Key: 196947141
• Report Number: 3005075853-2020-03189
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014317
• UDI-Public: 10705036014317
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: PSE45A
• Device Catalogue Number: PSE45A
• Device Lot Number: T9585U
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention