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
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
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.

• 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: 12189891
• Report Number: 2951238-2021-00370
• Device Sequence Number: 1391129
• Product Code: FEM
• UDI-Device Identifier: 15019778004655
• UDI-Public: 15019778004655
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2021
• Report Date (Section F): 06/23/2021

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?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Date Report to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other