MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. A CORD; ACTIVE CORD

Model Number MAJ-860

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

Patient Problems Numbness (2415); Electric Shock (2554); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2021-00369.

Event Description

The customer reports while preparing for an unspecified procedure using a wm-dp2 workstation and a maj-860 active cord (along with a valleylab generator and bovie), the endoscopy technician experienced an electrical shock while connecting an electrosurgery accessory (boston scientific single use polypectomy snare).It is reported the technician's gloves were wet and the generator was powered on at the time he attempted to connect the snare.The technician declined an emergency room visit for evaluation at the time and continued to work the remainder of the day.The technician's current condition is described as unable to work due to "his arm and hand are still swollen and numb." the devices were used for the remained of the day with no further issues reported.Biomed checked units and found no issues.The maj-860 was inspected with no visible damage noted.Biomed has removed the non-olympus generator from use and replaced with another unit on a separate cart/ roll stand.The olympus cord (maj-860) and bovie were checked out by biomed, and no malfunctions were identified.The olympus maj-860 has been replaced with a boston scientific active cord.No further issues reported.Case with patient identifier (b)(6) reports the wm-dp2 workstation.Case with patient identifier (b)(6) reports the maj-860 (this report).

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.Device history review (dhr): the lot number was not provided, dhr for this device was completed for one year prior to the date of occurrence.No abnormalities were detected in the dhr that relatd to the reported issue.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ·do not connect any equipment or inspect any connections when the electrosurgical unit is on.This could cause operator or assistant injury, such as thermal injury.Conclusion summary: the definitive cause of the reported event could not be determined.Based on the available information, the possible cause: the event description indicates that the a cord had been connected with electrosurgical accessory when the power of the electrosurgical unit was turned on.For the reason stated above, a likely mechanism causing an electrical shock might be the following: 1) an attempt was made by the user to connect the a cord and the electrosurgical accessory with wet gloves.2) the plug of the electrosurgical accessory or a cord got wet in state of description stated above.3) when the a cord and electrosurgical accessory were connected, electric current flowed through the adhered liquid.This caused an electric shock to the user.

• Brand Name: A CORD
• Type of Device: ACTIVE CORD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12188021
• MDR Text Key: 262175103
• Report Number: 8010047-2021-09049
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170062872
• UDI-Public: 04953170062872
• Combination Product (y/n): N
• PMA/PMN Number: K023280
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-860
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VALLEYLAB GENERATOR, BOVIE, BS SNARE.; VALLEYLAB GENERATOR, BOVIE, BS SNARE
• Patient Outcome(s): Other