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

Catalog Number	72203299S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, the spider 2 tenet was overheating when it was moved.Surgery was completed with a back-up device instead.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and found a drape clip missing.No accessories included.A functional evaluation found the device motor runs continuously and slender arm would not lock.It was noted during testing oil was found inside casing and bottom of motor.No overheating was noted.The piston migration was at 3.0 inches.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a component failure.Factors that could have contributed to the reported event include a seal failure that can result in the loss of oil, which can lead to air getting into the hydraulic system and cause the device to take an extended period to pressurize, which can cause the battery to get warm.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18704372
• Report Number: 1643264-2024-00102
• Device Sequence Number: 7396223
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: 885554029673
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown