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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY Back to Search Results
Model Number A22001A
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported, the telescope's light guide connector was loose.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6) hospital (added due to character limitation in respective field).
 
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Brand Name
TELESCOPE, 12°, 4 MM
Type of Device
HYSTEROSCOPE, GYNECOLOGY
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19165808
MDR Text Key340969971
Report Number9610773-2024-01086
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020848
UDI-Public04042761020848
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/23/2024
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 NumberA22001A
Device Lot Number711853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/22/2024
Initial Date FDA Received04/23/2024
Was Device Evaluated by Manufacturer? No
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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