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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO CHOLEDOCHOSCOPE 8.5 FR X 50CM

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KARL STORZ ENDOVISION CMOS VIDEO CHOLEDOCHOSCOPE 8.5 FR X 50CM Back to Search Results
Model Number 11292VS
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation is pending return of the device.
 
Event Description
As per report received by the factory in (b)(6) from the nhs greater glasgow and clyde in the (b)(6): when using the scope, blue material come out of the distal tip into patient; it's a blue like fiber.
 
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Brand NameCMOS VIDEO CHOLEDOCHOSCOPE 8.5 FR X 50CM
Type of DeviceVIDEO CHOLEDOCHOSCOPE
Manufacturer (Section D)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton, ma
Manufacturer (Section G)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton, ma
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, ca 
2188201
MDR Report Key10094199
MDR Text Key198757672
Report Number1221826-2020-00061
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11292VS
Device Catalogue Number11292VS
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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