MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELONLAB ENT 200-240 V~ (KIT); HF - GENERATORS WITHOUT SOFTWARE

Model Number	WB991001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
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 palate surgery at an unknown date, the patient sustained necrosis on the tissue.No further information was provided so far, but there was no report of a malfunction for any of the olympus medical devices.
Additional Manufacturer Narrative
Correction: h6 - device manufacturer date device evaluation: the suspect medical device and the associated foot switch were returned to the manufacturer for investigation.The investigation confirmed that there is no malfunction of the devices.The celonprosleep plus electrode was not returned for evaluation/investigation.Therefore, the evaluation/investigation was performed exclusively on the basis of the information provided by the customer.Since the respective celonlab is in standard and no malfunction of the probes is reported, the electrodes are evaluated to be in standard.Therefore, this event/incident was attributed to use error.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 generator and the effected lot number of the electrodes without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: CELONLAB ENT 200-240 V~ (KIT)
• Common Device Name: HF - GENERATORS WITHOUT SOFTWARE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10851924
• Report Number: 9610773-2020-00268
• Device Sequence Number: 910109
• Product Code: GEI
• UDI-Device Identifier: 04042768910012
• UDI-Public: 04042768910012
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K032838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: WB991001
• Device Catalogue Number: WB991001
• Device Lot Number: 6082-1012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: OLYMPUS CELONPROSLEEP PLUS (WB990095)
• Outcome Attributed to Adverse Event: Required Intervention