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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ TELECAM-C CAMERA, CINE, ENDOSCOPIC, WITH AUDIO

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KARL STORZ TELECAM-C CAMERA, CINE, ENDOSCOPIC, WITH AUDIO Back to Search Results
Model Number 20212134
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 11/07/2020
Event Type  No Answer Provided  
Event Description
Did not have a patient at the start of the shift so i went back to help rn with her cystoscope set up. The physician wanted to make sure the bladder was not nicked during the cesarean section. After the set up, the imaging was not clear. We had the residents and attending come trouble shout the cystoscope as well but the image was still unclear. I had to call the main or to find another cystoscope. During this whole time, the patient was still on the or table and the team was waiting. This was over 30+ minute delay because there was only one tech scheduled on nights and i had to go over. Luckily, the main or charge nurse was able to come help us find all the pieces we needed in 300p and we were able to borrow their cystoscope at night. This is unsafe and luckily was not an emergent situation. We need a working cystoscope on the floor. I know an incidence like this happened a while ago according to md. She was also able to set up the cystoscope but the imaging was not clear. This is all the information we have available.
 
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Brand NameTELECAM-C
Type of DeviceCAMERA, CINE, ENDOSCOPIC, WITH AUDIO
Manufacturer (Section D)
KARL STORZ
2151 e. grand avenue
el segundo CA 90245
MDR Report Key11235663
MDR Text Key228873677
Report Number11235663
Device Sequence Number1
Product Code FTS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number20212134
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2021
Event Location Hospital
Date Report to Manufacturer01/27/2021
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?
Type of Device Usage Unkown

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