MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number PSD-60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced psd-60 will not be returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the psd-60.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that during the unspecified procedure, the physician tried to activate the high frequency output of the psd-60 for hemostasis.However the high frequency output could not be activated and the error code indicating s-cord malfunction/abnormality was displayed.The facility used the psd-60 in combination with the non-olympus endoscope (fujinon).The facility changed the psd-60 to the other unspecified similar device and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-00755 to provide the device evaluation results.The referenced psd-60 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the psd-60.Based on the information from the facility, it was known that the facility used the non-olympus endoscope combination with the psd-60 and the s-cord (olympus).However omsc stated that non-olympus endoscope was not allowed to combine psd-60 and s-cord in the instruction manual of psd-60.Therefore it was considered that the psd-60 did not detect the s-cord correctly consequently the error code was indicated.Omsc concluded that this phenomenon was attributed to the inappropriate handling of the user.Omsc stated the appropriate handling of the devices and the counter measures against abnormalities of psd-60 in the instruction manual of psd-60.Omsc checked the manufacture history of the psd-60, there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7463503
• MDR Text Key: 106866666
• Report Number: 8010047-2018-00755
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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
• Device Operator: Health Professional
• Device Model Number: PSD-60
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1