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

Catalog Number	TCR55
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
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.
Event or Problem Description
It was reported: malformed staples.It was reported that during the esophagectomy surgery, when severing gastric tissue, after fired, noted the staples malformed.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
Product complaint (b)(4).Batch # p5886e.Device evaluation summary: the analysis results found that one tcr55 reload 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, cut, and formed all the staples as intended.The device fired with no 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.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-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8278807
• Report Number: 3005075853-2019-16174
• Device Sequence Number: 13842153
• Product Code: GDW
• UDI-Device Identifier: 10705036013129
• UDI-Public: 10705036013129
• 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): 01/06/2019

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: 09/19/2022
• Device Catalogue Number: TCR55
• Device Lot Number: P4T55Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/06/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1