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

Model Number	72203301
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the battery could not be charged.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, 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 no issues were noted.A functional evaluation was performed.The battery charged normally on the test charger.The battery was placed in a test spider 2.The battery lost it's charge after 11 cycles.The complaint was confirmed.The root cause is associated with an energy storage problem.A review of the device history record 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.Factors that could have contributed to the reported event include degradation of the electrodes and electrolytes over time.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
• MDR Report Key: 11131317
• Report Number: 1643264-2021-00059
• Device Sequence Number: 3335338
• Product Code: GDC
• UDI-Device Identifier: 00885554023503
• UDI-Public: 00885554023503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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
• Device Lot Number: JAN072019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1