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

Model Number	XR30V
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u5az6h.(b)(4).The following was requested, but unavailable: could you please provide more details for "it didn't work"? 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? please provide details as to how the reload did not work.Did the reload lock out and would not work? did the reload begin to staple and cut, but then jammed? did the device staple, but there was no cut line? if the device cut and stapled, were there any staples missing from the staple line? how was the procedure completed? device analysis: 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 xr30v reload arrived with no apparent damaged and with 5 protruding staples in the pockets.No functional test could be performed due to the conditions of the reload.The event reported was confirmed and it is related an improper use of the device.It should be noted that when manipulating the device only the closing trigger should be grasp until ready to fire the device.Do not grasp the firing trigger before the device is to be fired.If the firing trigger is manipulated it could cause the staples to deploy partially or completely resulting in malformed staples and a premature lockout situation.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the professor tried to use the cartridge after installing it, but it didn't work.The surgery was completed after replacing it with a new product.It had no effect on the patient.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12192964
• Report Number: 3005075853-2021-04003
• Device Sequence Number: 16488180
• Product Code: GDW
• UDI-Device Identifier: 10705036013457
• UDI-Public: 10705036013457
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 02/17/2025
• Device Model Number: XR30V
• Device Catalogue Number: XR30V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1