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

Catalog Number	72201919
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during an acl procedure with meniscus suture, the camera control unit was overheating, and the image loss sharpness.It is unknown if there was a back-up device available or how the procedure was completed.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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.Device is not in contact with patient or user, as per this, this event is considered not reportable.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• 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: 20758471
• Report Number: 1643264-2024-00621
• Device Sequence Number: 9263683
• Product Code: GCJ
• UDI-Device Identifier: 03596010643094
• UDI-Public: 3596010643094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/31/2024
• 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 Age: 26 YR
• Patient Sex: Male