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

Catalog Number	TX60B
Medical Device Problem Codes	Failure to Form Staple (2579); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery the tx60g staples didn't deploy properly.Surgeon had to take another tx to complete the case.Bowel injury was reported, but not elaborated.Opened another tx60 device to complete the case, the procedure was successfully completed.
Additional Manufacturer Narrative
(b)(4).B3: exact date is unk assumed first day of the month.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.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 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: was the trigger advanced with no staples deployed? were there missing staples from the staple line? if the device deployed staples, what was the appearance of the staples (b-formation, irregular, legs straight)? please provide more details for "bowel injury " how was the case completed? 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 8/22/2024.Corrected data d4: udi#.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/6/2024.D4: batch #890c62.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 tx60b device arrived with no apparent damaged and with a reload present inside a plastic bag.The reload was received fully fired.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.No malformed staples were noted at any time during the testing.In addition, a tyvek was received along with the device.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: 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.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 890c62, 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19941594
• Report Number: 3005075853-2024-05824
• Device Sequence Number: 17995770
• Product Code: GDW
• UDI-Device Identifier: 10705036003342
• UDI-Public: (01)10705036003342(17)290228(10)890C62
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/06/2024

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: TX60B
• Device Lot Number: 890C62
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 08/23/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/23/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown