MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CMOS VIDEO NEUROSCOPE; NEUROSCOPE VIDEO

Model Number 11161VK

Device Problem Misfocusing (1401)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The distal tip lens was found to be off position inside the assembly, an external cut in angle cover and blurry image.The scope was shipped to the account in may of 2019.

Event Description

Allegedly per the customer, at the beginning of an etv/cpc procedure, the video screen turned red and the image display appeared like broken glass.The surgeon abandoned the procedure.There was no harm to the patient.

• Brand Name: CMOS VIDEO NEUROSCOPE
• Type of Device: NEUROSCOPE VIDEO
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10283933
• MDR Text Key: 199136435
• Report Number: 9610617-2020-00077
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11161VK
• Device Catalogue Number: 11161VK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• 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): Required Intervention