MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. CMOS VID. NEUROSCOPE 8.5 FR X 350MM

Model Number 11161VK

Device Problem Melted (1385)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/06/2021

Event Type  Injury  

Manufacturer Narrative

The evaluation of the failed scope has yielded no cause due to product manufacture or design.The evaluation also found the angle cover was melted; the working channel has a leak; the shaft is bent; dents in the tip; and the handle housing was found soiled.The device shows signs of maintenance and care issues.Further testing provided the electronics within the shaft is incapable of getting hot enough to have melted the angle cover material.Note: a new report was needed instead of a supplement due to the need to correct the manufacturer's number, in the mdr report number, and also the manufacturer's name.

Event Description

During an endoscopic 3rd ventriculostomy, while removing the scope at the end of procedure, there seemed to be resistance.Tissue was found to be adhered to the side of scope; cautery was used to remove scope.The procedure was completed with no other surgical intervention required and, per dr.(b)(6), the patient does not have any neurologic consequences.

• Brand Name: CMOS VID. NEUROSCOPE 8.5 FR X 350MM
• Type of Device: NEUROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 8004210837
• MDR Report Key: 11814751
• MDR Text Key: 250283350
• Report Number: 1221826-2021-00036
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K161112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11161VK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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: 20 MO
• Patient Weight: 12