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	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and it was noted that the enclosed footswitch¿s cable was completely severed near the male connector.A functional evaluation was performed.A known good test battery was installed in the unit.The unit¿s main switch was engaged to pressurize the unit.The unit pressurized and locked as designed.The unit was left pressurized for approximately 2 hours.The unit was physically touched by hand at 20 minutes intervals during this two hour period and the enclosure and battery areas were never hot to the touch.The factory test footswitch was connected to the unit and the unit¿s limbs were then manipulated for approximately 8 minutes.The unit was then physically touched by hand again and the unit stayed at a normal temperature.The battery that was sent in with the unit was charged and then connected to the unit.The unit was pressurized for 1 hour and the unit was checked for overheating.No overheated areas were observed.The complaint of ¿getting hot¿ was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.
Event or Problem Description
It was reported that the device was getting hot.No significant delay or patient injury reported.

• 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: 7627336
• Report Number: 1643264-2018-00482
• Device Sequence Number: 2324185
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: (01)00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1