MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POSITIONER SPIDER LIMB; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number 7210569

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

It was reported that the device was not working properly; the foot pedal is slow.No back-up device was available.Nor delay or patient injury was reported.

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and it was noted that the foot switch cover was broken.The valve assembly and switch was removed from the cover and it was also noted that the switch and valve assembly contained internal rust and corrosion.A functional evaluation revealed that the foot pedal was slow to depressurize the spider when it was depressed.The complaint was confirmed and the root cause was determined to be corrosion within the foot pedal assembly which infiltrated the foot pedal relief valve causing the valve to not efficiently release air when opened by the foot pedal plunger.

• Brand Name: POSITIONER SPIDER LIMB
• Type of Device: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8015134
• MDR Text Key: 125444292
• Report Number: 1643264-2018-00824
• Device Sequence Number: 1
• Product Code: FWZ
• UDI-Device Identifier: 03596010511201
• UDI-Public: 03596010511201
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• 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: Unknown
• Patient Sequence Number: 1