MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO BRONCHOSCOPE; FLEXIBLE BRONCHOSCOPE

Model Number	11900BP
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/09/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Per the factory in (b)(4), upon evaluation massive thermal damages were found.Several functions were defective.The diagnosed damages were found to be not caused by a product defect.The electrical power provided by the scope itself is not capable to heat up the distal end to product damages like the present ones.Therefore; root cause most likely is related to the in combination used laser device (as reported: limax laser).The factory also stated in their report to (b)(6), " we would like to remind, that it needs to be ensured that power to laser probes is not applied until the active parts have left the instrument channel and are in user's field of vision.Activation in the instrument channel may lead to serious injury and damage to the video bronchoscope.Furthermore, it must be ensured that power is only applied when there are no flammable gases in the operating field or in the proximity of the video bronchoscope.".
Event or Problem Description
Per the factory in (b)(4), allegedly there was an event occurred in (b)(6) during a procedure using a flexible video -bronchoscope and a laser device limax laser, airway fire caused by laser and resulted in patients death.

• Brand Name: VIDEO BRONCHOSCOPE
• Common Device Name: FLEXIBLE BRONCHOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9695161
• Report Number: 9610617-2020-00015
• Device Sequence Number: 2422423
• Product Code: EOQ
• UDI-Device Identifier: 04048551227367
• UDI-Public: 4048551227367
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11900BP
• Device Catalogue Number: 11900BP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death