MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELONLAB ENT 100-120 V~ (KIT); ELECTROSURGICAL DEVICE AND ACCESSORIES

Model Number WB991007

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Electric Shock (2554)

Event Date 09/16/2020

Event Type  Injury  

Event Description

It was reported that the unit had no output and it was not firing.The unit was showing a signal that the probe was not in the correct place even when it was.In addition, the physician reported that the unit is shocking patients in addition to the probes not working when properly placed in the turbinate anatomy.The user facility further reported that there were actually two patients involved.Both of the patients had a nasal submucous turbinate reduction procedure.There was no reported permanent damage with both patients and no additional intervention provided to the patients.This report is 1 or 2 reports and this is related to patient identifier number (b)(6).

• Brand Name: CELONLAB ENT 100-120 V~ (KIT)
• Type of Device: ELECTROSURGICAL DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10849687
• MDR Text Key: 216649433
• Report Number: 2951238-2020-00516
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910074
• UDI-Public: 04042768910074
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2020,11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB991007
• Device Catalogue Number: WB991007
• Device Lot Number: 13175W500010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2020
• Date Report to Manufacturer: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: WB990210 (5 PCS/BOX)
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 91