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

Model Number	MH-969
Medical Device Problem Codes	Break (1069); Sparking (2595)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon receipt of the device, an evaluation will be performed and a supplemental report will be submitted.
Event or Problem Description
The service center received a report that a mh-969, lot number unknown, sparked and snapped in half during a procedure.It was reported that a physician was using the mh-969 with a generator when the physician stepped on a pedal to activate the device and the mh-969 originally did not work.Unexpectedly, after a short period of time, the mh-969 sparked and snapped in half.The physician replaced the mh-969 and the generator and completed the unspecified procedure after a delay in the intended procedure to replace the equipment.It was reported there was no patient death or injury.

• 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: 9608392
• Report Number: 8010047-2020-00943
• Device Sequence Number: 584960
• Product Code: GEI
• UDI-Device Identifier: 04953170048548
• UDI-Public: 04953170048548
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K023280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MH-969
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1