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

Model Number	72200561
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference number: case-(b)(4).
Event or Problem Description
It was reported that during the set up inspection, the image is disconnected every time the cable is moved from the camera side.Suspecting damaged cable or loose contact.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was returned to the designated complaint station for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection performed by service site noted worn front housing and cable.Functional evaluation by service site noted bad image and image loss when the cable is flexed at the strain relief.The complaint has been confirmed.Factors, unrelated to the manufacturing and design of the device that could have contributed to the damage include fatigue from repeated bending of the cable during extended use and crushing or shear force induced on the cable inconsistent with normal use.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.

• Brand Name: 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: 11388228
• Report Number: 1643264-2021-00818
• Device Sequence Number: 3382138
• Product Code: GCJ
• UDI-Device Identifier: 03596010591104
• UDI-Public: 03596010591104
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 72200561
• Device Catalogue Number: 72200561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1