MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD, HD 1200, AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72203360
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during acl knee surgery, the both camera heads were not giving any image on the monitor display.A backup device was available to complete the procedure with no delay or other complications.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, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Event or Problem Description
It was reported that during acl knee surgery, both camera heads were not giving any image on the monitor display.A backup device was available to complete the procedure with no delay or other complications.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Reassessment found that the alleged device is not a smith+nephew product.As a result, smith+nephew is not responsible for reporting according to 21 c.F.R.Part 803.3.Additionally, manufacturer has been notified of the event.If further details are provided confirming there is a sn product involved in the event, our files will be updated and the event will be reassessed accordingly.

• Brand Name: CAMERA HEAD, HD 1200, AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11310613
• Report Number: 3003604053-2021-00036
• Device Sequence Number: 19774948
• Product Code: GCJ
• UDI-Device Identifier: 03596010657497
• UDI-Public: 3596010657497
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K014158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 72203360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 03/04/2022
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/16/2021; 03/04/2022
• 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