MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P; SAW, POWERED, AND ACCESSORIES

Model Number	72201919
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that camera control unit overheated.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10, 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.The lid was dented.The lid and front bezel were not flush.A functional evaluation was performed.No issues were noted.The device was left on for approximately two hours and did not overheat.All cooling fans were functional.No burned components were observed.No abnormal smell was noted.The device passed functional testing.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.No containment or corrective actions are recommended at this time.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 was documented appropriately.There were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that may have contributed to the reported event include a defective fan.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 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 was documented appropriately.There were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: CAMERA CONTROL UNIT, HIGH DEF, 560P
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• 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: 14973921
• Report Number: 1643264-2022-00237
• Device Sequence Number: 5195149
• Product Code: HAB
• UDI-Device Identifier: 03596010643094
• UDI-Public: 03596010643094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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: 72201919
• Device Catalogue Number: 72201919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 08/05/2022; 09/28/2022
• Initial Report FDA Received Date: 07/10/2022
• Supplement Report FDA Received Date: 08/08/2022; 09/30/2022
• 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