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

Model Number	PPH01
Medical Device Problem Codes	Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was received: how was the bleeding control? manual suturing could you please clarify if there were any patient consequences? none could you please clarify if was any change in the post-operative care of the patient as a result of the event? none.
Event or Problem Description
It was reported that during a hemorrhoidectomy, when triggering the device (lever) very sluggish, no click.Renewed triggering.Bleeding due to incomplete staple suture row (second release) with subsequent manual suture.
Additional Manufacturer Narrative
(b)(4).Sent: 06/28/2022.D4: batch # r5c153.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the pph01 device arrived with the knife damaged, the breakaway washer was present and with an off-center cut due to this condition two staples were stuck on the washer.In addition, an unformed staple was received taped on the device.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident: despite the damage in the knife.The staple line was complete, and the staples meet the staple form release criteria.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 instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14625732
• Report Number: 3005075853-2022-03687
• Device Sequence Number: 20083825
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 11/30/2023
• Device Model Number: PPH01
• Device Catalogue Number: PPH01
• Device Lot Number: R9584M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown