MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-DP2 WORKSTATION SET 1 (US); ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

Model Number	K10020639
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Electric Shock (2554); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional 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 - 00370.
Event or Problem 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 (this report).Case with patient identifier (b)(6) reports the maj-860.
Additional Manufacturer Narrative
This report is being updated to provided investigation findings.Investigation summary/conclusion: the reported event details state the user experienced a shock by the exchange of a surgical energy system and cable.No mention is made of the workstation/transformer beyond requesting its voltage rating and noting that it was inspected and no visible defect was noted.The following is included as an interpretation of information provided: the injured party (user) was reported to have been shocked while connecting an electrosurgery accessory with the: "the valleylab force2" still powered on.This is the surgical energy generator.Given that the purpose if this unit is to supply high voltage energy for the purpose of surgical procedures it would seem a reasonable precaution to require that the unit be powered off before accessing the conductive end of the equipment, this caution has not been taken.The suggested conclusion is thus that the olympus equipment has no fault and a combination of customer error (in changing electro-surgical accessory while source is powered on) and possible failure of non-olympus equipment ("valleylab force 2 " surgical energy system) is potentially the cause.

• Brand Name: WM-DP2 WORKSTATION SET 1 (US)
• Common Device Name: ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• MDR Report Key: 12189888
• Report Number: 9611174-2021-00019
• Device Sequence Number: 11484354
• Product Code: FEM
• UDI-Device Identifier: 15019778004655
• UDI-Public: 15019778004655
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: K10020639
• Device Lot Number: 21976900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VALLEYLAB GENERATOR, BOVIE, BS SNARE
• Outcome Attributed to Adverse Event: Other