MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL SPIDER 2 TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	72203299S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spider 2 tenet stopped working; 2 batteries were replaced but it would still not work.No patient injury reported.
Additional 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 no complaint related issues were observed.A functional evaluation revealed that the hydraulic pump motor was inoperable.The pre-pressure test jig was used to bypass the unit's pcb and fuse.The unit's pump motor still would not engage when driven directly by the pre-pressure test jig.This eliminated the pcb and fuse as the root cause.The pump motors brushes were then removed and examined and there were no issues with them.The complaint is confirmed and the root cause has been determined to be an open electrical circuit within the hydraulic pump motor.Manufacturing records show that the device was released to distribution as a service replacement in (b)(4) 2015.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REPL SPIDER 2 TENET 7615
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7006644
• Report Number: 1643264-2017-01539
• Device Sequence Number: 16563238
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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 Catalogue Number: 72203299S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1