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

Catalog Number	PXW35
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to an unknown procedure the patient experienced that the wound approximation is not so tightly closed, and that the wound bursts more than usual when the patient returns for checkup.They also complained that they have to change staples and that don't adhere well enough.
Additional Manufacturer Narrative
(b)(4).Date sent 10/3/2024 d4 batch # unk.B3: only event year known: 2024 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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 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? would the account like to have a call with the ethicon team? if yes, please provide 3 dates and times that work for them (est)? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/16/2024 corrected data: 6.Health effect - impact code.

• 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: 20360740
• Report Number: 3005075853-2024-07467
• Device Sequence Number: 20836145
• Product Code: GDT
• UDI-Device Identifier: 10705036002673
• UDI-Public: 10705036002673
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: PXW35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown