MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IRR. EXT'R, HIGH FLOW, DOUBLE VALVE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72200831

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

It was reported by customer that device presented metal crescent on the monitor.

Manufacturer Narrative

One high flow double valve irrigation extender was returned for evaluation.Visual assessment shows the device has been repaired by a third party as the irrigation extender body and compression sleeve components have been welded together.The repair has resulted in a misalignment of the device which would cause the reported field of view issue.Further investigation is not warranted at this time.

• Brand Name: IRR. EXT'R, HIGH FLOW, DOUBLE VALVE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7113396
• MDR Text Key: 94878371
• Report Number: 1219602-2017-01537
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200831
• Device Lot Number: 50322442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1