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

Model Number	72200561S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (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 broken connector contacts.Functional evaluation revealed noisy screen display with no visible image.The complaint has been confirmed.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include excessive force used to insert or remove the camera head card edge connector from the camera control unit.A review of the device history records showed there were no indications to suggest that 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 or Problem Description
It was reported that there was a blurry image seen in the camera head's field of view.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had no visible image which makes it a reportable event.

• 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
• MDR Report Key: 12055459
• Report Number: 1643264-2021-02154
• Device Sequence Number: 14364395
• Product Code: GCJ
• UDI-Device Identifier: 03596010606808
• UDI-Public: 03596010606808
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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
• 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: 05/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1