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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG BIMOBILE; SURGICAL PRESS
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WALDEMAR LINK GMBH & CO. KG BIMOBILE; SURGICAL PRESS Back to Search Results
Model Number 184-360/00
Device Problems Material Fragmentation (1261); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2023
Event Type  malfunction  
Event Description
Metal splinter has loosened from the threaded rod.[customer].
 
Event Description
Metal splinter has loosened from the threaded rod.
 
Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
 
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Brand Name
BIMOBILE
Type of Device
SURGICAL PRESS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, hamburg 22339
GM  22339
Manufacturer Contact
andreas brandt
barkhausenweg 10
hamburg, hamburg 22339
GM   22339
MDR Report Key17324042
MDR Text Key319105510
Report Number3004371426-2023-00058
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,Followup
Report Date 07/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2023
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 NumberC137159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received06/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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