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

Catalog Number	PRW35
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 6/20/2024.D4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.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? 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
It was reported that after an open unknown procedure, patient had surgery in the middle of the night, the staples fell out post surgery.Patient will be going back today to be sutured shut from all three layers.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/15/2024 d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.Additional information was requested, and the following was obtained: what procedure was being performed? open colon resection.How was the issue addressed? the nurse practitioner had steri stripped at the bedside then contacted dr.(b)(6) and when he looked at the wound and it had some redness, so he placed a wound vac on the patient.Describe the staple formation? at the time the staples looked fine.Was the stapling done by one or two individuals? what is the experience of the user in using ethicon skin staplers? he¿s been using skin staplers his entire career.Were the skin edges approximated with forceps ahead of the stapler? yes.Was the device fired plastic to plastic? yes.Can details regarding additional wound management protocols be provided? see above.What is the current patient status? patient did just fine and is well.This complaint happened on our proximate regular rotating stapler.The account has since moved to the wide skin stapler and dr.(b)(6) has not had any issues since.

• 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: 19576715
• Report Number: 3005075853-2024-04566
• Device Sequence Number: 11776426
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: 10705036013020
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: PRW35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/15/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female