MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC CAMERA HEAD NON-AC HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200561S
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-2021-00047341-1.
Event or Problem Description
It was reported that camera head had a cable problem, poor electrical contact during set up for an unknown procedure.It is unknown when it happened relative to surgery.It is unknown if a backup device was avail ale or how the issue was resolved.It is unknowns if there a delay.No injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during set up, the camera head had a cable problem, poor electrical contact.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B5: updated.H10 h3, h6: the reported device was received for evaluation.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed that there was loss of image when the connector is moved.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 has been associated with an electrical component failure.Factors that could have contributed to the reported events include internal damage to the connector.No containment or corrective actions are recommended at this time.

• Brand Name: SVC CAMERA HEAD NON-AC HD560H
• 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: 11663599
• Report Number: 1643264-2021-01383
• Device Sequence Number: 3084553
• Product Code: GCJ
• UDI-Device Identifier: 03596010606808
• UDI-Public: 03596010606808
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: 72200561S
• Device Catalogue Number: 72200561S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/31/2023
• 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