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	12/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hinge joint is slipping.No patient injury or significant time delay 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 a missing drape clip was observed.A functional evaluation was performed and a known good battery was installed in the unit.The unit pressurized normally.The digital fish scale was attached and the standard 30 pound load test was administered.The hinge joint held as designed at 30 pounds of pressure.The load was then increased to 50 pounds of pressure.The hinge joint also held as designed even under 50 pounds of pressure.The proximal, hinge and distal joints all held under 50 pounds of pressure.There was no pneumatic fluid noticed around the proximal, hinge and distal joints.The piston migration was checked and it registered at 2.1 inches; which is indicative of hydraulic fluid loss.There was excess oil within the enclosure and also excess oil was dripping from the rear of the bimba cylinder.The seal had failed within the cylinder allowing an excess amount of pneumatic fluid to escape.The complaint was verified and the root cause was a seal failure within the bimba cylinder.

• 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: 7173802
• Report Number: 1643264-2018-00028
• Device Sequence Number: 1250330
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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 Catalogue Number: 72203299S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1