MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 70°; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202088

Device Problem Bent (1059)

Patient Problem Injury (2348)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that prior to commencing an arthroscopy procedure, the healthcare professional noted that a dent was in the side of the scope which made the healthcare professional change to a different scope.A large labral tear was identified while using the back-up device, the surgeon opted to abandoned the procedure.No reported patient injuries.No other complications were noted.

Manufacturer Narrative

Visual inspection was performed and showed the scope has been used in the field.The scope has severe distal tip and fiber damage.The scope is also dented with internal cracked lenses.These deficiencies are caused by contact with another source.No manufacturing related defects were observed.Use error most likely contributed to the device condition.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 70°
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: james gonzales ; 7000 west william cannon; austin, TX 01810 ; 5123585706
• MDR Report Key: 6002632
• MDR Text Key: 57161120
• Report Number: 3003604053-2016-00102
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

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: 72202088
• Device Lot Number: BBK 1065674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• 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