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

Catalog Number	TLH30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the radical resection of esophageal cancer surgery, after fired, noted some staples in the tissue were malformed, some staples fell off (not in the tissue).Changed to new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Batch # r57z10.Device analysis: the analysis results showed that the tlh30 device arrived with no apparent damaged and with no reload present.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The device fired without any difficulties and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8532582
• Report Number: 3005075853-2019-18263
• Device Sequence Number: 1303720
• Product Code: GDW
• UDI-Device Identifier: 10705036013228
• UDI-Public: 10705036013228
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 02/27/2023
• Device Catalogue Number: TLH30
• Device Lot Number: R40A2J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/20/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRH30.; TRH30