MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72201919
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a rotator cuffs and ligaments arthroscopy, the image on a camera head was intermittent; therefore, it was changed for another one, but the same failure remained; then they tested it with a third camera head, and it displayed a screen of only one color without image.For that reason, they concluded that the image issue was with the camera control unit.The procedure was completed using an s+n back up device.There was a delay greater than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.Please refer to the instructions for use for precautions and warnings related to the use of the device.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: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 18306821
• Report Number: 1643264-2023-00731
• Device Sequence Number: 6278515
• Product Code: GCJ
• UDI-Device Identifier: 03596010643094
• UDI-Public: 03596010643094
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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 Catalogue Number: 72201919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/08/2024
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG