MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*HCS HEMORR CIR STAPL; STAPLE, IMPLANTABLE

Catalog Number PPH01

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only year (2019) is known.Batch # r5a61y device evaluation summary: the analysis results found that the pph01 device arrived with the knife damaged, the breakaway washer was present and with an off-center cut.The device was reloaded with staples and the device was tested for functionality and it fired.The staple line was complete; however, the washer cut was not a perfect circle due to the damaged knife.It appears possible that the anvil was pushed far enough off center to result in an off center cut of the breakaway washer and damage the knife by pressing it hard enough against the anvil.This situation normally occurs when the tissue is not evenly distributed in the device.However, it could not be determined what may have caused the anvil to become off center.It should be noted that ensuring that the tissue thickness is within the indicated range, and that it is evenly distributed in the device.Excess tissue on one side may result in unacceptable staple formation and can result in staple line leakage.Please reference the instructions for use for additional information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the customer indicated that there was a device malfunction.No more information is available.There were no patient consequences reported.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9077655
• MDR Text Key: 200665166
• Report Number: 3005075853-2019-22101
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (y/n): N
• PMA/PMN Number: K030925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Catalogue Number: PPH01
• Device Lot Number: R94L9E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1