MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY POWER LED 175 LIGHT SOURCE

Model Number 20161401-1

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

We have relevant warnings in the ifu on the light source/20161401-1 and the flexible scope/ 11272vn that was attached to the light source: light source: warning: the light port and the housing may be hot.Warning: risk of burns: the light outlet may heat up to over 41°c.Flexible scope: warning: high energy light radiated through flexible video-urethro-cystoscopes may give rise to high temperatures in front of the light outlet, at the end faces of the light guide and at the tip of the flexible video-urethro-cystoscope.Prolonged direct contact of light-emitting surfaces on tissue can lead to burns, this must therefore be avoided at all costs.Warning: even after the proximal connector is removed from the light source, surfaces will remain hot for a period of time (risk of user being burnt).Device not returned yet.

Event Description

Allegedly, after the procedure was completed, the nurse removed a flexible scope that was connected to the light source and was placing it in the sterilization tray when the proximal cable tip of the flexible scope made contact with the inside of her forearm causing a burn.The burn blistered and she treated with ointment; burn has healed.

Manufacturer Narrative

Unable to duplicate customer complaint.During the evaluation, unit is working properly; it passes all the functional, safety tests.

• Brand Name: POWER LED 175 LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6045893
• MDR Text Key: 58019173
• Report Number: 9610617-2016-00159
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 20161401-1
• Device Catalogue Number: 20161401-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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): Other
• Patient Age: 33 YR