MAUDE Adverse Event Report: KARL STORZ ENDOVISION STROBO VIDEO-RHINO-LARYNGOSCOPE

Model Number 11101VNSK

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

There was no report of a malfunction of the subject device; device will not returned for evaluation.Our ifu contains following warning: even after the supply connector is removed from the light source, surfaces will remain hot for a period of time (risk of user being burnt).

Event Description

Allegedly, during a procedure, the physician sustained a burn to her hand when removing video scope's video adaptor from the light source connector.

• Brand Name: STROBO VIDEO-RHINO-LARYNGOSCOPE
• Type of Device: STROBO VIDEO-RHINO-LARYNGOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7982388
• MDR Text Key: 124288042
• Report Number: 1221826-2018-00081
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11101VNSK
• Device Catalogue Number: 11101VNSK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention