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)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during a lobectomy procedure, the stapler formation was broken.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # p55a3a.Device analysis: the analysis results showed that the xr30v reload arrived with no apparent damaged and with only 11 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 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.For further details please refer to the instruction for use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7947361
• Report Number: 3005075853-2018-13386
• Device Sequence Number: 16250250
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2018

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: 12/31/2021
• Device Catalogue Number: XR30V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/15/2018
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1