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

Model Number	MAJ-860
Health Effect - Clinical Codes	Inflammation (1932); Numbness (2415); 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.Case with patient identifier (b)(6) reports the maj-860 (this report).

• Brand Name: A CORD
• Common Device Name: 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: 12187951
• Report Number: 2951238-2021-00369
• Device Sequence Number: 1391128
• Product Code: GEI
• UDI-Device Identifier: 04953170062872
• UDI-Public: 04953170062872
• 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: MAJ-860
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Event Location: Hospital
• 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