MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER 2 BATTERY TENET 7609; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	72203301
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that the spider 2 battery tenet had a "fire" caused by one of the batteries or the battery charger.It is unknown whether the event happened during surgery and if there was a patient involvement.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection was performed on the product.The device had a date of (b)(6) 2021 etched into it.A functional evaluation was performed.The device was placed on a known good battery charger for approximately 3 hours.The device did not overheat.The test charger did not overheat.The device was placed into a known good test spider 2.40 cycles were performed with no issues.The battery did not overheat.The complaint was not confirmed.It was determined the device did not contribute to the reported event.Factors that could have contributed to the reported event include failure of a concomitant 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 complaint history review concluded this was an isolated 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: SPIDER 2 BATTERY TENET 7609
• 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: 12936831
• Report Number: 1643264-2021-02454
• Device Sequence Number: 20031177
• Product Code: GDC
• UDI-Device Identifier: 00885554023503
• UDI-Public: 00885554023503
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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 Model Number: 72203301
• Device Catalogue Number: 72203301
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 04/05/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown