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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. 4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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ARTHREX INC. 4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number AR-3352-5530
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

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) -line (b)(6) -(b)(4). Device history record review revealed nothing relevant to this event. When used with a synergy system set to conditions for maximum energy output, the scope temperature at the exposed threads of the light guide to scope junction exceeded the maximum user temperature (for unlimited touch duration) of 48 degrees c. Prolonged, direct contact with human tissue at this temperature may cause a thermal injury. Testing using a known, good scope was performed under the same conditions. The resulting temperature at the same location was slightly higher than the returned scope. User manual 950-0047-01 does inform the user of the risk of burns associated with prolonged exposure to intense illumination as required by (b)(4), medical electrical equipment - part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment. 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) line (b)(6)), or the 4k synergy camera head, ar-3210-0029 ((b)(4) line (b)(6)). 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.

 
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Brand Name4K LAPAROSCOPE, 30°, 5.5X300MM, HI-MAG
Type of DeviceLAPAROSCOPE, 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 Key7285130
MDR Text Key100525879
Report Number1220246-2018-00055
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK941541
Number of Events Reported1
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
Date FDA Received02/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAR-3352-5530
Device LOT Number10140675
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/09/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/21/2018 Patient Sequence Number: 1
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