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

Catalog Number	TL90
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.As a lot/batch was not provided, a device history could not be performed.Attempts were 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.Can you please clarify, when the "staple line didn't hold closed", what was the staple formation (unformed, malformed, open leg, etc.)? or were there staples missing from the staple line?.
Event or Problem Description
It was reported that during a bowel resection the staple line didn't hold closed.A competitive stapler was used to complete the procedure.There were no patient consequences reported.No product will be returned.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: can you please clarify, when the "staple line didn't hold closed", what was the staple formation (unformed, malformed, open leg, etc.)? or were there staples missing from the staple line? the staples didn't form all the way.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7252092
• Report Number: 3005075853-2018-07864
• Device Sequence Number: 1022749
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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 Catalogue Number: TL90
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1