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

Model Number 72203967

Device Problem No Display/Image (1183)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted frayed and cut cord with exposed wires.Functional evaluation revealed that there was flickering and loss of image when the cable is flexed near the stain relief.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include an internal damage to the cord.A review of the device history record showed there were no indications to suggest 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.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the camera head was not working properly.The incident occurred before the procedure; therefore, there was no patient involvement.Results of investigation have concluded that this unit had no image which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: 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: 11462629
• MDR Text Key: 239177549
• Report Number: 1643264-2021-00967
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885556629833
• UDI-Public: 00885556629833
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 72203967
• Device Catalogue Number: 72203967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/11/2021
• 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