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

Model Number	PXW35
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Device evaluation summary: the analysis results confirmed that the pxw35 device was returned nonfunctional.The device was received with the cartridge detached from the handle.Further analysis shows that lifter and lifter spring were loose of cartridge.No functional test was performed due to the condition of the device.The dhr review could not be conducted, as no batch number or lot number of the complaint was provide.No conclusion could be reached as to how the cartridge became damaged.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.
Event or Problem Description
It was reported that during an unknown procedure, the device was broken off at the first firing.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Common Device Name: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9652740
• Report Number: 3005075853-2020-00644
• Device Sequence Number: 14067397
• Product Code: GDT
• UDI-Device Identifier: 10705036002673
• UDI-Public: 10705036002673
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 11/19/2019

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 Model Number: PXW35
• Device Catalogue Number: PXW35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1