MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD UNIT 30MM; STAPLE, IMPLANTABLE

Catalog Number	TR30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch # unk.Date of event: 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.
Event or Problem Description
It was reported that during an unknown procedure, malformation of staple.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # k5e921.Investigation summary: the analysis results found that the tr30 was received with no apparent damage.The reload was received fully loaded with staples.The reload was tested for functionality with a test device and it fired and formed all the staples as intended.The staple line was complete and the staples meet the staple form release criteria.Event described could not be confirmed as no malformed staples were observed and the cartridge was received fully fired.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7947658
• Report Number: 3005075853-2018-13395
• Device Sequence Number: 428450
• Product Code: GDW
• UDI-Device Identifier: 10705036013266
• UDI-Public: 10705036013266
• 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): 09/18/2018

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: 10/12/2018
• Device Catalogue Number: TR30
• Device Lot Number: K4DW19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1