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

Catalog Number	72203299S
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, while using the spider 2 switch drape connection port, the arm released and dropped.It is unknown how the procedure was completed; however no surgical delay was reported.No patient complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5¿.
Event or Problem Description
It was reported that, during an unknown procedure, while using the spider 2 switch drape connection port, the arm released and dropped, it would randomly give out.Surgery was resumed, after a non-significant delay, with a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection was performed on the product.A foot switch was also returned.No issues were noted.A functional evaluation was performed.A test switch drape jig was utilized.The test jig de-pressurized the device as designed.The device was left pressurized for approximately 30 minutes with the test jig attached.No failures were observed.The reported complaint was not verified.The root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include issues during setup of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of device records shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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: 14573436
• Report Number: 1643264-2022-00190
• Device Sequence Number: 12306272
• Product Code: GDC
• UDI-Device Identifier: 00885554029673
• UDI-Public: 00885554029673
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 05/13/2022; 08/15/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/13/2022; 08/16/2022
• 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