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

Model Number	PRW35
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.(b)(4).Device analysis: the analysis results confirmed that the prw35 device was returned with three jammed staples in the cartridge nose, the staples were manually removed and the device was tested for functionality, the device fired the 30 remaining staples as intended and the staples were noted to have the proper box shape.As part of our quality process, the manufacturing records of this lot was reviewed, and the manufacturing standards were met prior to the release of this lot.No conclusion could be reached as on what caused the staples to become jammed.Although there is no direct evidence of use error, the instructions for use do contain the following caution: evert and approximate skin edges as desired.Several techniques are suggested: with one tissue forcep, pull skin edges together until edges evert or with two tissue forceps, pick up each wound edge individually and approximate the edges 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.Squeeze the trigger until you touch plastic trigger to plastic handle.Release the trigger and remove the instrument from the fired staple.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, device fired the first few staples correctly then jammed.Surgery was delayed by 4-minutes with no fragments generated.The procedure was completed successfully with no patient consequences.

• Common Device Name: REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11108788
• Report Number: 3005075853-2021-00007
• Device Sequence Number: 11661489
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: 10705036013020
• Combination Product (Y/N): N
• PMA/510(K) Number: K833357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 06/22/2025
• Device Model Number: PRW35
• Device Catalogue Number: PRW35
• Device Lot Number: U40G39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1