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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 11/12/2024.D4 batch # unk.B3: unknown; captured as awareness date.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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 during an unknown procedure that the staples did not close properly.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent 12/31/2024.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned sample.Visual analysis of the returned sample determined that one prw35 device was received empty along with a tyvek with no apparent damage and 4 malformed staples were returned inside a plastic bag, however, as the device was received empty, we are unable to investigate further the event description.No conclusion could be reached on what caused the malformed staples returned.The event described could not be confirmed as the device was received empty.This report is not intended to deny that you experienced a problem with the device and the reported complaint could not be confirmed.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis batch records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device lot number 131d98, and no non-conformances were identified.

• 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: 20662317
• Report Number: 3005075853-2024-08589
• Device Sequence Number: 7285482
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020(17)290531(10)131D98
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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 Catalogue Number: PRW35
• Device Lot Number: 131D98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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
• Patient Sex: Unknown