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

Model Number	PXW35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure a piece of metal came out of the stapler.A new device was used to complete the case with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Device analysis: 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 pxw35 device was returned nonfunctional.Further analysis shows that lifter and lifter spring were loose of cartridge.No functional test was performed due to the condition of the device.No conclusion could be reached as to how the cartridge became damaged.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use 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.Manufacturing records could not be completed as the lot number was not provided.

• Common Device Name: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14217979
• Report Number: 3005075853-2022-02712
• Device Sequence Number: 4208217
• Product Code: GDT
• UDI-Device Identifier: 10705036002673
• UDI-Public: 10705036002673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown