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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH STONE CRUSHER GRASPING FORCEPS; ENDOSCOPE, AC-POWERED AND ACCESSORIES
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OLYMPUS WINTER & IBE GMBH STONE CRUSHER GRASPING FORCEPS; ENDOSCOPE, AC-POWERED AND ACCESSORIES Back to Search Results
Catalog Number A20710A
Device Problems Break (1069); Out-Of-Box Failure (2311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2016
Event Type  malfunction  
Event Description
The olympus stone crusher grasper rotating ball on the grasper broke.This is the second time this device has broken in the same manner.Manufacturer response for olympus stone crusher, (brand not provided) (per site reporter): the manufacturer claims that it is a processing error in csp.This has happened numerous times and each instrument has broken in the same manner.Whether it is a coincidence or not, it is very strange that it breaks that way.
 
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Brand Name
STONE CRUSHER GRASPING FORCEPS
Type of Device
ENDOSCOPE, AC-POWERED AND ACCESSORIES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
3500 corporate pkwy
center valley PA 18034
MDR Report Key5842701
MDR Text Key51020142
Report Number5842701
Device Sequence Number1
Product Code GCP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberA20710A
Device Lot Number158W-0017
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO.
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