MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_PROXIMATE LINEAR STAPLER TL; STAPLE, IMPLANTABLE

Model Number	TL90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown; captured as awareness date (b)(6) 2021.Please capture product code as: unk_proximate linear stapler tl.Batch # unknown.(b)(4).The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported "received notice of claim which states claimant underwent a hemicolectomy for distal transverse colon cancer (adenocarcinoma) during which a side to side, functional end to end anastomosis was created using a gia stapler and a ta stapler was used to close the enterotomy.On the fifth postoperative day, patient underwent repair of pinhole anastomotic leak.Surgeon noted no gross contamination or significant free air upon opening.An internal hernia was also repaired: however very limited information was provided.Claim form states patient received an ileostomy on (b)(6) 2019; however, no records are provided with any details of treatment or findings.".
Additional Manufacturer Narrative
(b)(4).Date sent: 05/17/2021.

• Brand Name: UNK_PROXIMATE LINEAR STAPLER TL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11693343
• Report Number: 3005075853-2021-02118
• Device Sequence Number: 3137923
• Product Code: GDW
• UDI-Device Identifier: 10705036013198
• UDI-Public: 10705036013198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: TL90
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR