MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", E TYPE; HF- GENERATORS

Model Number	WA90001A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified procedure at an unknown date the patient sustained a perforation of the palate.The surgeon felt that the issue was caused by the generator¿s output being too strong.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation did not reveal any malfunctions of the hf-generator but found the device to be working correctly.No abnormality, defect, failure or malfunction could be determined.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be conclusively determined.However, since the generator was evaluated as in standard, this event/incident can in all likelihood be attributed to use error.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", E TYPE
• Common Device Name: HF- GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11391508
• Report Number: 9610773-2021-00082
• Device Sequence Number: 19676476
• Product Code: GEI
• UDI-Device Identifier: 04042761082952
• UDI-Public: 04042761082952
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K160639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: WA90001A
• Device Catalogue Number: WA90001A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SINGLE-USE HF ELECTRODE; UNSPECIFIED SINGLE-USE HF ELECTRODE
• Outcome Attributed to Adverse Event: Required Intervention