MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWERED LED 175 LIGHT SOURCE; LED LIGHT SOURCE

Model Number 175 LIGHT SOURCE

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

Two devices contributed to this scenario - filled add'l report for other device (1 of 2).During surgical preparation, the light source was inadvertently turned on prior to attaching the scope.Due to the heat generated by this light source and the contact with the surgical drape, the top surgical drape melted.This drape was not in contact with the pt and the light had been in contact with the drape for less than 2 mins when the surgical tech asked that it be turned off.The second and third layers of surgical draping remained intact and the sterile field was maintained.The veteran was unharmed in this event and the procedure was completed without any other complications.The equipment was removed from service and review by biomed engineering showed the equipment was functioning as designed.Concern for potential engineering defect.Although we know there is always the potential for a light source fire, the amount of time in which this occurred is troubling.Other companies we have used had engineering controls in place to prevent direct exposure to the light source fiber tip.Additionally, it is not readily apparent when in the surgical field if the light cord is in standby or on, due to the intensity of the cord tip while in standby mode.There is a powered led panel that indicates whether it is in standby or on, but is not readily viewable to all those in the surgical field.Fda safety report ids# (b)(4).

• Brand Name: POWERED LED 175 LIGHT SOURCE
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ SE & CO. KG
• MDR Report Key: 8931205
• MDR Text Key: 155793620
• Report Number: MW5089306
• Device Sequence Number: 2
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 175 LIGHT SOURCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 67