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

Catalog Number	TL90
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) batch # unk the lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Maude report mw5075373.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.
Event or Problem Description
It was reported that the surgeon experienced an anastomotic leak where the device was used.On re-exploration it was noted that the staple line had an obvious defect.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7416304
• Report Number: 3005075853-2018-09054
• Device Sequence Number: 554894
• Product Code: GDW
• UDI-Device Identifier: 20705036013195
• UDI-Public: 20705036013195
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 12/31/2022
• Device Catalogue Number: TL90
• Device Lot Number: R9219M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/10/2018
• 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