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	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.Additional information was requested and the following was obtained: how was the issue of "staples did not form properly" addressed? were there any patient consequences? if yes, please describe.Stapler did not form properly there was loose stapler after firing.No patient consequences.Dr.Has used vascular suture for same.
Event or Problem Description
It was reported that during an unknown procedure the reload of the stapler did not form properly.
Additional Manufacturer Narrative
(b)(4).Device evaluation: the analysis results showed that one xr30v reload was received fully fired and damaged as the rear cap was detached and missing allowing the retainer pin to slide out of the reload.No functional test was performed due the condition of the device.It is possible that the reload was not loaded correctly.To reload the device the tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated and a click is heard.If the instructions are not follow the reload may became damage.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7596548
• Report Number: 3005075853-2018-10591
• Device Sequence Number: 2222302
• 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,Followup
• Report Date (Section B): 05/18/2018

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: 11/14/2018
• Device Catalogue Number: XR30V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1