MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH90
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Maude report mw5077945.
Event or Problem Description
It was reported that during an exploratory laparotomy hartman procedure, ¿intraoperatively stapler would not properly fire across the bowel.Surgeon used suture to close the rectal stump.Suture line was inspected and noted to be intact and hemostatic.¿ no additional information was provided.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7722883
• Report Number: 3005075853-2018-11567
• Device Sequence Number: 1451730
• Product Code: GDW
• UDI-Device Identifier: 20705036013249
• UDI-Public: 20705036013249
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: TLH90
• Device Lot Number: P92X1R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1