MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD UNIT 60MM; STAPLE, IMPLANTABLE

Catalog Number	TR60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Month and day unknown.Only year (2018) is known.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Can you please clarify the event.Did the device lock out and could not be fired at all (no staples delivered)? or was the trigger advanced with no staples deployed? or did the device begin to deliver a staple line and could not be completed (incomplete staple line)? if yes, what was the appearance of the staples (b-formation, irregular, legs straight)?.
Event or Problem Description
It was reported that during an unknown procedure, firing did not fully complete.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch #: k5el7d.Device evaluation: the analysis results showed that the tr60 reload arrived with no apparent damage with and fully loaded with staples.The reload was tested for functionality with a test device 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.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: can you please clarify the event.Did the device lock out and could not be fired at all (no staples delivered)? or was the trigger advanced with no staples deployed? or did the device begin to deliver a staple line and could not be completed (incomplete staple line)? if yes, what was the appearance of the staples (b-formation, irregular, legs straight)? the device delivered the staple line but the distal part of some staples did not form b-shape, it was irregular.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7579419
• Report Number: 3005075853-2018-10424
• Device Sequence Number: 19221305
• Product Code: GDW
• UDI-Device Identifier: 20705036013270
• UDI-Public: 20705036013270
• 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,Followup
• Report Date (Section B): 05/13/2018

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: 11/07/2018
• Device Catalogue Number: TR60
• Device Lot Number: L4E51Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 05/13/2018
• Supplement Date Received by Manufacturer: 06/07/2018; 06/29/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/28/2018; 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1