MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/6 ROW BL; STAPLE, IMPLANTABLE

Catalog Number	6TB45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch number: n54h01.Investigation summary: the analysis results found that an 6tb45 device was received with no apparent damaged with no reload present.The clamping mechanism was noted to be damaged.No functional test was performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the yoke teeth were found broken.Although no conclusion could be reached as to how the yoke teeth became broken, this damage can occur when excessive force is applied to the closing trigger when the jaws are clamped on tissue thicker than indicated.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that during the laparoscopic rectal resection surgery, could not fire when severing rectum tissue on the firing.Changed another reload, could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: 45MM ARTICNG LNR CUTR/6 ROW BL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8772476
• Report Number: 3005075853-2019-20290
• Device Sequence Number: 2638709
• Product Code: GDW
• UDI-Device Identifier: 10705036000877
• UDI-Public: 10705036000877
• Combination Product (Y/N): N
• PMA/510(K) Number: K070887
• 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
• Report Date (Section B): 05/14/2019

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: 03/22/2021
• Device Catalogue Number: 6TB45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/09/2019
• Patient Sequence Number: 1