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

Catalog Number	XR30V
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n5788y.Event month and day unknown.Only year (2017) is known.Device evaluation: the analysis results showed that the xr30v reload arrived with no apparent damaged and partially loaded with only 12 staples present and all protruding.No functional test could be performed due to the conditions of the reload.It should be noted that when manipulating the device only the closing trigger should be grasped 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.For further details please refer to the instruction for use.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an unknown procedure, the firing trigger wasn't available, even though tissue wasn't that thick (it was a vessel).The surgeon changed to another cartridge, and it worked well.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7500580
• Report Number: 3005075853-2018-09732
• Device Sequence Number: 1813757
• Product Code: GDW
• UDI-Device Identifier: 20705036013454
• UDI-Public: 20705036013454
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2017

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: 10/18/2021
• Device Catalogue Number: XR30V
• Device Lot Number: N4MA96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1