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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. PROTOSCOPES, SIGMOIDOSCOPES, ACC. SIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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KARL STORZ ENDOSCOPY-AMERICA, INC. PROTOSCOPES, SIGMOIDOSCOPES, ACC. SIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number 13901NKS
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 11/10/2016
Event Type  Malfunction  
Event Description

While removing the video sigmoidoscope from the light source, the sigmoidoscope body separated from the light source connection and the flexible endoscope sheath. This is the second occurrence of this type of failure on this sigmoidoscope model. Review with the user indicated that they did follow correct removal procedure. This scope was the exchange scope replacing a scope that had the same damage with separation of the light connector body and flexible sheath. Manufacturer response for video sigmoidoscope, (brand not provided) (per site reporter: manufacturer noted this was a warranty device delivered two months ago. Manufacturer called unit in. Biomedical engineering is requesting report on failure.

 
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Brand NamePROTOSCOPES, SIGMOIDOSCOPES, ACC.
Type of DeviceSIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo CA 90245
MDR Report Key6098767
MDR Text Key59744087
Report Number6098767
Device Sequence Number1
Product Code FAM
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 11/10/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2016
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number13901NKS
Device Catalogue Number13901NKS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/10/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2016
Device Age40 dy
Event Location Hospital
Date Report TO Manufacturer11/10/2016
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

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