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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

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STRYKER ENDOSCOPY-SAN JOSE 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Catalog Number 0502880426
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2014
Event Type  malfunction  
Event Description
It was reported that the unit caught onto tissue.
 
Manufacturer Narrative
Upon additional information, bleeding occurred, thus constituting a new awareness.Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The product was returned and the failure mode was not confirmed.Visual inspection: no physical damage was seen on the sheath.In addition, no protrusions or sharp edges were seen on the distal tip.However, rust was seen on the stop cock.The probable root cause for the device catching on tissue is likely due to use error.The probable root causes for the rust on the stop cock could be due to 1) improper sterilization methods, 2) insufficient drying, or 3) improper storage conditions.In sum, the product was returned and the failure mode was not confirmed.
 
Event Description
It was reported that the unit caught onto tissue.
 
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Brand Name
24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
thomas shafer
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key4086325
MDR Text Key4744895
Report Number0002936485-2014-00709
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/15/2014
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 Catalogue Number0502880426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/05/2014
Initial Date FDA Received09/12/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/05/2014
Was Device Evaluated by Manufacturer? Yes
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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