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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG PRESS, STAINLESS STEEL; SURGICAL PRESS
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WALDEMAR LINK GMBH & CO. KG PRESS, STAINLESS STEEL; SURGICAL PRESS Back to Search Results
Model Number 184-360/00
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
The report is delayed due to original classification of the case as non-reportable.Due to the recent fda inspection we reevaluated the complaint in comparison to similar complaints with different outcomes and therefore determined that it is reportable.We have addressed this observation in capa-23-08.
 
Event Description
Thread cut together and stuck.
 
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Brand Name
PRESS, STAINLESS STEEL
Type of Device
SURGICAL PRESS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweh 10
hamburg, hamburg 22339
GM  22339
Manufacturer Contact
annerike-tizia hucklenbroch
barkhausenweg 10
hamburg, hamburg 22339
GM   22339
MDR Report Key17641713
MDR Text Key322181307
Report Number3004371426-2023-00091
Device Sequence Number1
Product Code LZO
UDI-Device Identifier04026575185948
UDI-Public04026575185948
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K190535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number184-360/00
Device Catalogue Number184-360/00
Device Lot NumberB809071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Initial Date Manufacturer Received 05/25/2021
Initial Date FDA Received08/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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