MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR TRANSTAR STAPLER SET

Model Number	STR5G
Health Effect - Clinical Code	Fistula (1862)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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? what is the surgeons experience with the str5g device? how many times was the device fired? were there any difficulties with the device in the initial procedure? were there any issues noted with staple formation in the initial surgery? if yes, what was their form/shape? were there any issues observed with staple formation on the re-op? if yes, please explain.How was the fistula addressed?.
Event or Problem Description
It was reported that during a prolapse, the patient has a fistula after surgery.

• Brand Name: CONTOUR TRANSTAR STAPLER SET
• Common Device Name: CONTOUR TRANSTAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9865168
• Report Number: 3005075853-2020-01761
• Device Sequence Number: 11580274
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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 Model Number: STR5G
• Device Catalogue Number: STR5G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention