MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. STAMMBERGER; BUR, EAR, NOSE AND THROAT

Catalog Number 46105

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2021

Event Type  malfunction  

Event Description

After opening the stammberger bipolar, the surgical tech questioned if the inner working channel looked defective.To be safe we pulled it for service evaluation and had the previous cases bipolar iuss for use.

• Brand Name: STAMMBERGER
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 12778648
• MDR Text Key: 280521381
• Report Number: 12778648
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 46105
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White