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

Model Number	UES-40
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device has not been returned for evaluation.The exact cause of the reported event cannot be determined.Follow up with the user facility indicated the device has been working as intended since the event.If additional information becomes available, a supplemental report will be filed.The instruction manual for the unit provides warning which states: "before each case, inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument.Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.Confirm that the connections of the power cord, foot switch, patient plate, a cord, hand piece, adapter, bipolar electrode, bipolar cord and saline cord are secure and correct.If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.".
Event or Problem Description
The user facility reported that a physician could not remove a polyp during a procedure while using a ues-40 electrosurgical unit.The user facility used their ues-40 surgmaster electrosurgical unit with unnamed 3rd party snares.The reporter said that the physician was unable to remove the polyp as the snares only made it halfway to three quarters of the way through the polyp.The physician believed the problem resided with the generator and not the snares.The generator did not display an error code and it seemed to have its normal audible tone while in use.The patient went to the hospital two days later and had the polyp removed, without problems.The reporter also said that they have been using the electrosurgical unit since the event without any problems.The snares were disposed and not sent to the original manufacturer for evaluation.

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8962417
• Report Number: 8010047-2019-03193
• Device Sequence Number: 11367127
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: UES-40
• 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: 08/05/2019
• Initial Report FDA Received Date: 09/04/2019
• 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