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

Model Number	TX60B
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2022 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 lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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 field as appropriate.
Event or Problem Description
It was reported that during a urology procedure the stapler had incomplete staple formation to include completely unformed staples where the staple legs were straight.The staple line unraveled and the lumen was open.Sutured close.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 08/02/2022.Additional information: product code is a tx30b.
Additional Manufacturer Narrative
(b)(4) date sent: 08/24/2022 d4: batch # 681a53 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 tx30b device arrived with no apparent damage and with no reload present.The device was tested for functionality with a test reload xr30b, k5al0e and it fired and formed all the staples as intended.The device fired without any difficulties and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: squeeze the closing trigger until a click is heard.The instrument is in an intermediate position, the pin is fully seated in the anvil capturing the tissue, and the jaws are partially open.Reposition tissue within the instrument if desired.Squeeze the closing trigger and the handle fully together until a second click is heard.The closing trigger is now latched to the handle and the jaws are clamped onto the tissue, which is ready to be stapled.The firing trigger will simultaneously move down to the ready-to-fire position.Before firing, check to ensure the retaining pin is seated in the anvil.If the pin is not properly positioned, staples may not form properly, which may result in leakage or disruption of the staple line.Fire the instrument by pulling the firing trigger back completely against the closing trigger until a click is heard, signifying the staples are fully formed.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15027913
• Report Number: 3005075853-2022-04612
• Device Sequence Number: 15010310
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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 Model Number: TX60B
• Device Catalogue Number: TX30B
• Device Lot Number: 681A53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 08/09/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown