MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE

Catalog Number	XR60B
Medical Device Problem Codes	Failure to Fire (2610); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 5/13/2024.D4 batch # unk.B3: only event year known: (b)(6) 2024 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.No lot number was provided therefore a device history could not be done.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 there were no staples in the reload when the fired.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/27/2024.D4: batch # 957a49.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the xr60b reload arrived with no apparent damage and fully fired.No functional test was performed due to condition of the reload.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: continue to grasp and manipulate the instrument using the closing trigger until ready to fire the instrument.Do not grasp the firing trigger before the instrument is to be fired.Attempting to force the trigger to complete the closing stroke with too much tissue or thickened tissue may result in poor staple formation with the loss of staple line integrity and subsequent leakage, disruption, or poor healing.In addition, instrument damage or failure may result.The event described could not be confirmed as the reload was received fully fired.A manufacturing record evaluation was performed for the finished device batch number 957a49, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Could you please provide more details of device malfunction: the reload was empty from start, there were no staplers in it.2.Were there staples in the reload prior to firing? no.3.When the device fired, were there no staples deployed? no, it was empty.

• Common Device Name: STAPLE, IMPLANTABLE
• 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: 19299663
• Report Number: 3005075853-2024-03576
• Device Sequence Number: 5856070
• Product Code: GDW
• UDI-Device Identifier: 10705036013464
• UDI-Public: 10705036013464
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K020779
• 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): 06/27/2024

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: XR60B
• Device Lot Number: 957A49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown