MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELONPROBREATH (5 PCS); ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number WB990210

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  Injury  

Event Description

The customer reports during a turbinoplasty procedure using a celonprobreath, two devices failed upon initial clinical use (during the same procedure).The procedure was cancelled.There were no adverse effects to the patient and no treatment/intervention was required as a result of cancelling the procedure.The procedure has since been completed.The patient has not had a post-op follow-up appointment after the repeat procedure.Case with patient identifier (b)(6) reports one device.Case with patient identifier (b)(6) reports the other device.

• Brand Name: CELONPROBREATH (5 PCS)
• Type of Device: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 15668796
• MDR Text Key: 302399608
• Report Number: 2429304-2022-00101
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 14042768902106
• UDI-Public: 14042768902106
• 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: 09/28/2022,10/25/2022

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
• Device Operator: Health Professional
• Device Model Number: WB990210
• Device Catalogue Number: WB990210
• Device Lot Number: 1000093664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 82 KG