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	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a subtotal gastrectomy procedure.The device didn't close a staple line.The surgeon who used the product stated that this was the first time he came across with such a problem, generally he uses the product all the time and he is pleased with the outcome.However, he only saw the issue with this lot numbered product.The clips did not get out of the cartridge and didn't close the staple line.Meaning, there were no lost clips through the staple line.The procedure was completed by suturing the open line manually by the surgeon.There was no consequence to the patient.The device was discarded.
Additional Manufacturer Narrative
(b)(4).Additional information was obtained: lot: n4mc8t.Manufacture date: 12/20/2017 expiration date: 11/30/2021 the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7109875
• Report Number: 3005075853-2017-06667
• Device Sequence Number: 1272709
• Product Code: GDW
• UDI-Device Identifier: 20705036013126
• UDI-Public: 20705036013126
• 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): 11/10/2017

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: 11/30/2021
• Device Catalogue Number: TCR55
• Device Lot Number: N4MC8T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1