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

Catalog Number	PRW35
Medical Device Problem Codes	Mechanics Altered (2984); Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 2/6/2025.D4 batch # unk.# (b)(4).B3: exact date is unk.Assumed 1st day of the month.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what is meant by ¿destroyed unlaying tissue¿? what procedure was being performed? how was the issue addressed? describe the staple formation? was the stapling done by one or two individuals? what is the experience of the user in using ethicon skin staplers? were the skin edges approximated with forceps ahead of the stapler? was the device fired plastic to plastic? can details regarding additional wound management protocols be provided? what is the current patient status? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Per user facility medwatch form, #(b)(4), during an unknown surgery; stapler was not dispending staples properly and destroyed unlaying tissue, per surgeon, and incision had to be reopened and repositioned to close wound.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/24/2025.Additional information was requested, and the following was obtained: what is meant by ¿destroyed unlaying tissue¿? further information unknown at this time.What procedure was being performed? per the medical record, patient underwent bilateral breast debridement implant removal placement of tissue expanders surgery.How was the issue addressed? unknown at this time.Describe the staple formation? unknown at this time.Was the stapling done by one or two individuals? unknown at this time.What is the experience of the user in using ethicon skin staplers? unknown at this time.Were the skin edges approximated with forceps ahead of the stapler? unknown at this time.Was the device fired plastic to plastic? unknown at this time.Can details regarding additional wound management protocols be provided? unknown at this time.What is the current patient status? per the medical record, patient following-up as an outpatient with oncologist.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21324923
• Report Number: 3005075853-2025-01029
• Device Sequence Number: 8457174
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020(17)290930(10)307D57
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PRW35
• Device Lot Number: 307D57
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown