MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA ¿ VIDEO SYSTEM CENTER

Model Number CV-180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Shock (2072); Numbness (2415)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.The cv-180 instruction manual provides users several warnings to mitigate shock.¿before connecting the endoscope connector to the lightsource, make sure that it is completely dry.Otherwise, electric shock or equipment damage can result.Strictly observe the following precautions.Failure to do so may place the patient and medical personnel in danger of an electric shock.When the light source is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components.Such contact may cause unintended current flow to the patient.Keep fluids away from all electrical equipment.If fluids are spilled on or into the unit, stop operation of the light¿ source immediately and contact olympus.Do not prepare, inspect or use this light source with wet hands.

Event Description

Olympus was informed that during or setup, the facility¿s technician was shocked while connecting the gastrointestinal videoscope to the lightsource and video processor.It was reported that the video system might have been powered on but the light source was not.The user facility believes that the videoscope cable may have been connected to the light source when the incident occurred.A second technician present in the room reported observing a flash at the same time the injured technician yelled out from the shock.The technician was sent to the user facility¿s emergency room and was treated for numbness in the hand.The technician is currently doing well and has since returned to full duties.Additionally, it was reported that the user facility¿s biomed removed the light source and video system from service to perform a grounding and current leakage test.No anomalies were found with light source or video system.The biomed also, visually inspected the equipment and found no visible burn marks on the system.The two devices were powered by a non-olympus power source, which was also tested and inspected with no anomalies found.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation.Please see the updates to sections: d10 g4, g7,h2, h3, h6 and h10.The device was returned to the service center for evaluation.A visual inspection was performed on the received device and found the video connector lock latch is slightly worn out.No other physical anomalies was noted.An electrical patient safety leakage test was performed; the cv-180 video processor passed the electrical safety leakage test.The video processor was tested in conjunction with the customers¿ clv-180 light source (sn# (b)(6) ) and gif-h180j endoscope (sn# (b)(6)).No electrical shock or anomalies were noted.Based on the evaluation, the reported complaint was not duplicated or reproduced.However, based on the information provided by the customer, it is likely the customer was shocked due to not all components were properly connected and powered off.The customer stated ¿the cv-180 might have been powered on but the clv-180 was not powered on.The maj-1430 cable was not connected to the scope.The maj-1430 cable might have been connected to the cv-180.¿ in addition, the customer is using a non-olympus power boom to power the cv-180 video processor and clv-180 light source.When the maj-1430 video cable is not connected to the scope, and is connected to a powered cv-180, this is an electrical safety hazard as the maj-1430 scope connector has exposed metal if no scope is connected.The exposed metal provides a direct electrical connection between the cv-190 connector contact pins to the maj-1430 scope connector (exposed metal).If the end-user is in contact with the exposed metal when plugging into a powered cv-190, an electrical shock/discharge is to be expected.

• Brand Name: EVIS EXERA ¿ VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8589654
• MDR Text Key: 144390066
• Report Number: 2951238-2019-00819
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLV-180 SERIAL NUMBER (B)(4); GIF-H180J SCOPE SERIAL NUMBER (B)(4); MAJ-1430 CABLE; STRYKER BOOM; CLV-180 SERIAL NUMBER (B)(4); GIF-H180J SCOPE SERIAL NUMBER (B)(4); MAJ-1430 CABLE; STRYKER BOOM
• Patient Outcome(s): Required Intervention