FDA Adverse Event Other Summary report: N

STORZ LIGHT SOURCE, EIN: 200-43384

MDR report key: 19648065 · Received June 28, 2024

Report

Report Number
MW5156854
Event Type
Other
Date Received
June 28, 2024
Date of Event
September 27, 2023
Report Date
June 26, 2024
Manufacturer
KARL STORZ SE & CO. KG
Product Code
GCT
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

THE SURGICAL TECH PASSED OFF CAMERA AND LIGHT CORD TO NURSE WHO THEN PLUGGED BOTH INTO CONSOLE. THE SURGICAL TECH PLACED SCOPE, CAMERA, AND LIGHT CORD ON STERILE DRAPE OVER PATIENTS PELVIC AREA. THE SURGEON PROCEEDED TO OPERATE BY TURNING ON THE LIGHT THROUGH THE CAMERA FUNCTIONS IN ORDER TO WHITE BALANCE SCOPE. THE SURGEON THEN STATED THAT SHE DID NOT SEE ANY LIGHT COMING THROUGH THE SCOPE. THE NURSE THEN WALKED OVER TO THE LIGHT BOX TO VERIFY THE LIGHT CORD WAS MATCHED CORRECTLY WITH THE CORRECT LIGHT DIAL. THE SECOND SURGICAL TECH IN THE ROOM QUICKLY VOICED TO LOCATE THE LIGHT CORD. THE NURSE QUICKLY POWERED DOWN THE LIGHT BOX WHILE CORD WAS BEING LOCATED. THE LIGHT CORD WAS FOUND ON THE DRAPE THAT HAD BEEN TRI FOLDED AND IT WAS NOTED BY THE SURGEON AND THE TECH THAT THE LIGHT CORD WAS NOT ATTACHED TO THE CAMERA. THE TEAM EXAMINED THE DRAPE AND IT WAS FOUND TO HAVE A BURN WHOLE THROUGH THE FIRST LAYER OF THE TRI FOLD THAT WAS FURTHEST AWAY FROM THE PATIENT. THE SECOND TWO LAYERS WERE NOTED TO BE INTACT. THE WHOLE TEAM PROCEEDED TO EXAM PATIENTS SKIN THAT WAS UNDER THAT DRAPE AND NO HARM WAS FOUND TO THE PATIENT. THE SURGEON FELT COMFORTABLE TO PROCEED WITH CASE. AT THE END OF THE CASE THE WHOLE TEAM AGAIN RE-EXAMINED THE PATIENTS AREA THAT WAS UNDER THE DRAPE AND IT WAS STILL FOUND THAT NO HARM HAD REACHED THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
684729 STORZ LIGHT SOURCE, EIN: 200-43384 LIGHT SOURCE, ENDOSCOPE, XENON ARC GCT KARL STORZ SE & CO. KG XENON 300

Patients

Seq Age Sex Outcome Treatment
1 32 YR Female Other