MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA INC AIDA SCB DVD-M ENDOSCOPIC CAMERA

Model Number 292945 29

Device Problems Failure to Power Up (1476); Data Problem (3196)

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

Event Date 02/24/2012

Event Type  malfunction  

Event Description

Endoscopic camera failed to turn on during case; unable to store data.

• Brand Name: AIDA SCB DVD-M
• Type of Device: ENDOSCOPIC CAMERA
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA INC; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 5346405
• MDR Text Key: 35159249
• Report Number: 5346405
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 292945 29
• Other Device ID Number: CONTROL # 45144
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2015
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage