MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS; ARTHROSCOPE

Model Number 72203967S

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that the camera head was warm when use.It is unknown when the event happened relative to surgery.A back up device was available to complete the procedure.There was no delay, and no further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection did not identify any issues.Functional evaluation of the device did not reveal any malfunction.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications 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 was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include improper light guide diameter is in use for the current operative procedure.No containment or corrective actions are recommended at this time.

• Brand Name: SERVICE REPL CAMERA HEAD LENS INT SYS
• Type of Device: ARTHROSCOPE
• 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: 16061234
• MDR Text Key: 306520946
• Report Number: 1643264-2022-00489
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885556631980
• UDI-Public: 00885556631980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 72203967S
• Device Catalogue Number: 72203967S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other