MAUDE Adverse Event Report: CONMED LARGO LOOKING GLASS CAMERA HEAD - 4K 3MOS EYECUP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	AV41CHE
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the av41che, looking glass camera head - 4k 3mos eyecup, device was being used during a lobectomy procedure on 29apr24 when it was reported ¿we had a camera head fail in the middle of a lobectomy at a very compromising time of the case.The camera head was working fine until it image shook on the screen, then vibrated or shook followed by going completely pink on all screens.The surgeon was near an artery by the heart where he had a bleeder and was quite upset about it.The camera had was then rebooted successfully by unplugging and plugging back in and was used the remainder of the case.The surgeon commented to me after the case that this could¿ve been life-threatening to this patient.This is quite disturbing for me as i was in the room.He has filled an incident report with the hospital, so i am doing the same here with this incident report.His comment to me was this cannot happen during the middle of a case.¿.The procedure was completed without the use of an alternate device and a 5-minute delay was also reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation could not duplicate the reported issue.Additionally, evaluation found that three buttons are loose from the bezel.The device passed the 4k camera head fg sensor screening per (b)(4).The service history was reviewed, and no relationship to this complaint was found.A device history record review found a non-conformance related to the reported event.The ncr history was reviewed by quality engineering and found the defect was isolated to the sn (b)(6), no other ncs and no indication of a trend or any systemic issue.The cable assembly was replaced, and the camera was inspected and tested with no additional issues.As the issue was detected in process and the process controls are deemed adequate to detect the defect, it was determined that no further investigation was required.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised prior to using the camera head perform the following testing: 1.Turn on the looking glass system by pressing the power button.Ensure the color bar pattern appears on the monitor.2.Ensure the camera head connector led color ring is illuminated green.3.Connect the camera head cable to the cable connector interface.4.Ensure the camera head connector led color ring is illuminated blue.Point the camera head at a stationary object and check for the live video feed on the monitor.If the video image is not present or is interrupted, ensure proper connection of camera head cable to the cable connector interface.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the av41che, looking glass camera head - 4k 3mos eyecup, device was being used during a lobectomy procedure on (b)(6) 2024 when it was reported ¿we had a camera head fail in the middle of a lobectomy at a very compromising time of the case.The camera head was working fine until it image shook on the screen, then vibrated or shook followed by going completely pink on all screens.The surgeon was near an artery by the heart where he had a bleeder and was quite upset about it.The camera had was then rebooted successfully by unplugging and plugging back in and was used the remainder of the case.The surgeon commented to me after the case that this could¿ve been life-threatening to this patient.This is quite disturbing for me as i was in the room.He has filled an incident report with the hospital, so i am doing the same here with this incident report.His comment to me was this cannot happen during the middle of a case.¿.The procedure was completed without the use of an alternate device and a 5-minute delay was also reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: LOOKING GLASS CAMERA HEAD - 4K 3MOS EYECUP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19308988
• Report Number: 1017294-2024-00056
• Device Sequence Number: 12490356
• Product Code: GCJ
• UDI-Device Identifier: 30845854050761
• UDI-Public: (01)30845854050761(11)230215
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: AV41CHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic