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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE SCISSORS INSERT

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KARL STORZ SE & CO. KG CLICKLINE SCISSORS INSERT Back to Search Results
Model Number 34310MS-D
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Device has not yet been evaluated; it is in transit to the manufacturer, (b)(4).

 
Event Description

As per a vigilance report filed with national competent authority, swissmedic, by the factory in (b)(6): during a laparoscopic procedure, the jaws of the clickline scissors insert could no longer be closed intra-abdominally. To remove the instrument, the trocar had to be removed and a pair of pliers was used to close the jaws in order to bring the scissors insert through the orifice.

 
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Brand NameCLICKLINE SCISSORS INSERT
Type of DeviceSCISSORS
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 Key9777546
MDR Text Key198141610
Report Number9610617-2020-00030
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK935071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number34310MS-D
Device Catalogue Number34310MS-D
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/02/2020 Patient Sequence Number: 1
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