MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0 DEGREE; RIGID TELESCOPE 18CM 0 DEGREE

Model Number R7230AA

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.The facility provided no information pertaining to the event.Per the sales representative who saw pictures of the burn, noted that the burn appeared to be minor on left nostril and bacitracin had been applied.

Event Description

It was reported that during a sinus procedure the patient was burned on the left side of his nostril.

• Brand Name: HOPKINS TELESCOPE 0 DEGREE
• Type of Device: RIGID TELESCOPE 18CM 0 DEGREE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242118810
• MDR Report Key: 14306070
• MDR Text Key: 291305796
• Report Number: 9610617-2022-00062
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R7230AA
• Device Catalogue Number: R7230AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male