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

Model Number	TRT75
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts were made to obtain additional information and the following information was received: could you please provide more details for "reload pin were not deployed"? did the device staple? if the device stapled, was the staple line complete? if the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? did the device cut? if the device cut, was the cut line complete? were the cut line and staple lines equal? was the device fired across a staple line? did the reload lock out and would not work? how was the procedure completed? sales rep informed as he was not present in the case, above questions are difficult to answer for hospital staff.Attempts were made to retrieve the device.To date, no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, the "reload pins were not deployed." it is unknown how the procedure was completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/23/2021.H6: component code = g04.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the trt75 reload was received unfired with the forks broken off and with the left gripping surface damaged.No functional test was performed due to the condition of the reload.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It should be noted that product failure is multifactorial.The damage on the reload has consisted of an improper loading technique.Please reference the instruction for use for proper cartridge loading.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12421771
• Report Number: 3005075853-2021-05238
• Device Sequence Number: 17040390
• Product Code: GDW
• UDI-Device Identifier: 10705036013334
• UDI-Public: 10705036013334
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2021

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 Expiration Date: 01/28/2025
• Device Model Number: TRT75
• Device Catalogue Number: TRT75
• Device Lot Number: U4055C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown