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

Catalog Number	PXR35
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure the surgeon used the pxw35 skin stapler to appose wound edges post-operatively.Surgeon complained the following day that some of the clips had become undone.The surgeon needed to touch up the surgical wound closure using a suture.The surgeon observed undoing of staples on surgical wound.This was corrected with sutures.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/28/2023.D4 batch # unk.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 was the procedure? were there any issues with the device when it was originally used? 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? what was the appearance of skin staples at the time they were placed? 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: 3/7/2024.Additional information was requested, and the following was obtained:what was the procedure? laparotomy for small bowel obstruction.Were there any issues with the device when it was originally used? no, this surgeon is also a long-standing user of the device and nothing abnormal was initially noted.Was the stapling done by one or two individuals? 1, he used a pincet to appose the wound edges ahead of the skin stapler while he fires the device.What is the experience of the user in using ethicon skin staplers? satisfactory up until this issue which was met with surprise since he has not experienced this outcome before.Were the skin edges approximated with forceps ahead of the stapler? yes, as above was the device fired plastic to plastic? yes, the surgeon is a long-time user and fires plastic to plastic because he understands that this technique ensures that there is some wound edge aversion for better regranulation in the post operative phase.Can details regarding additional wound management protocols be provided? only that he had to re-suture part of the wound edge which came undone-presumably due to the malfunction of the skin staples according to the surgeon¿s assessment.What is the current patient status? the patient is discharges and no adverse effects were experienced except for this acute incident with would dehiscence.What was the appearance of the skin staples at the time they were placed? normal according to the surgeon¿s assessment.

• 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: 17833147
• Report Number: 3005075853-2023-06935
• Device Sequence Number: 3390429
• Product Code: GDT
• UDI-Device Identifier: 10705036002666
• UDI-Public: 10705036002666
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: PXR35
• Device Lot Number: 357C14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown