MAUDE Adverse Event Report: ARTHREX INC. 4K SYNERGYUHD4 BROADBAND CAMERA HD, AUTOCLVBL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number AR-3210-0029

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This submission is one of two from the same event., the other is (b)(4).The device was requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

The sales rep reported that during a laparoscopic colon resection the staff noticed the camera head became unusually warm.After the case was completed, the camera head and scope were placed on the sterile drapes covering the patient.While undraping the sterile drapes, the surgeon and staff noticed the camera head or scope became warm enough to burn the patient's skin.The burn mark resembled the outline of the camera head yet it is unknown if the burn was caused by the 4k laparoscope, ar-3352-5530 ((b)(4)), or the 4k synergy camera head, ar-3210-0029 ((b)(4)).Follow-up investigation: the settings on the device were brightness - 5, zoom - 0, gain - low, auto exposure window - medium, enhancement - 4, light source output - max, light source auto - off.Staff noticed midway through the case that the camera head and laparoscope were excessively warm.According to in room staff the first remark was 1.5 hours into the procedure.Case was completed as scheduled.Patient's burn was a heightened red area, discoloration that resembled the outline of the camera's coupler.The burn did not break the patient's skin.Hospital's protocol was followed: apply appropriate disinfectant, skin nourishing application.Patient was kept overnight but it was due to the procedure that was done and no due to the burn.Patient is recovering from the surgery normally.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This submission is one of two from the same event., the other is (b)(4).Device history record review revealed nothing relevant to this event.The evaluation found that the device met its functional requirements.The camera head did not operate above the maximum touch temperature requirement.Refer to the attached engineering report by m.Sharpe for additional details and data.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

The sales rep reported that during a laparoscopic colon resection the staff noticed the camera head became unusually warm.After the case was completed, the camera head and scope were placed on the sterile drapes covering the patient.While undraping the sterile drapes, the surgeon and staff noticed the camera head or scope became warm enough to burn the patient's skin.The burn mark resembled the outline of the camera head yet it is unknown if the burn was caused by the 4k laparoscope, ar-3352-5530 ((b)(4)), or the 4k synergy camera head, ar-3210-0029 ((b)(4)).Follow-up investigation: the settings on the device were brightness - 5, zoom - 0, gain - low, auto exposure window - medium, enhancement - 4, light source output - max, light source auto - off.Staff noticed midway through the case that the camera head and laparoscope were excessively warm.According to in room staff the first remark was 1.5 hours into the procedure.Case was completed as scheduled.Patient's burn was a heightened red area, discoloration that resembled the outline of the camera's coupler.The burn did not break the patient's skin.Hospital's protocol was followed: apply appropriate disinfectant, skin nourishing application.Patient was kept overnight but it was due to the procedure that was done and no due to the burn.Patient is recovering from the surgery normally.

• Brand Name: 4K SYNERGYUHD4 BROADBAND CAMERA HD, AUTOCLVBL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7285127
• MDR Text Key: 100530317
• Report Number: 1220246-2018-00056
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: 00888867216570
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-3210-0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other