MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*SKIN STAPLER-WIDE; REMOVABLE (SKIN)

Model Number	PXW35
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the staples took off.The staples did not hold.Passing the hand on them made them fall.Surgical delay.A suture by thread had been performed instead.No patient consequence.
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 batch/lot number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 07/22/2022.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 revealed that the pxw35 device was returned with no apparent damage, fully functional.In addition, an opened packaging was received.When tested for functionality the device fired and formed the remaining 25 staples as intended.The device fired without any difficulties and the staples were noted to have the proper box shape.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: with two tissue forceps, pick up each wound edge individually and approximate the edges.Or, with one tissue forcep, pull skin edges together until edges evert.Or, apply tension to either end of the incision, such that the tissue edges begin to approximate themselves.One forcep can be used to ensure that the edges are everted.Position the instrument over the everted skin edges, aligning the instrument arrow with the center of the incision at a 50° - 60° angle from the skin.Squeeze the trigger until you touch plastic trigger to plastic handle (plastic to plastic), then release the trigger and move the instrument off the incision.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Common Device Name: REMOVABLE (SKIN)
• 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: 14605452
• Report Number: 3005075853-2022-03645
• Device Sequence Number: 14980854
• Product Code: GDT
• UDI-Device Identifier: 10705036002673
• UDI-Public: 10705036002673
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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 Model Number: PXW35
• Device Catalogue Number: PXW35
• Device Lot Number: 666A09
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown