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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSS INSTRUMENTS, LTD./STEALTH SURGICAL, LLC. STEALTH KERRISON RONGEUR, MANUAL

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BOSS INSTRUMENTS, LTD./STEALTH SURGICAL, LLC. STEALTH KERRISON RONGEUR, MANUAL Back to Search Results
Model Number SS6995, SS6994, SS6993, AND SS6996
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2017
Event Type  malfunction  
Event Description
In light of tracking and trending for debris on sterile instruments, it was noted that the stealth kerrison's were found with bioburden after sterilization on multiple occasions. Several times per week we had an outside vendor to come and take apart the kerrisons for sterilization and found copious bone fragments and bioburden inside the instruments. Our process at that time would be to sterilize these instruments per manufacturers guidelines in between the outside vendor sterilizations. The amount of bioburden left inside these kerrisons was unacceptable and we stopped using them. We transitioned to the black kerrison's that were not required to take apart to clean. These black kerrisons were not safe to use. We had several complaints from surgeons that they were dangerous, and hard to use. We reverted back to the old kerrison's and put a plan in place that we would not utilize the instrumentation until the outside vendor had taken them apart to sterilize them completely between each case. Manufacturer response for kerrison, stealth kerrison (per site reporter)
======================
the director of sterile processing has been in contact with the manufacturer.
 
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Brand NameSTEALTH KERRISON
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
BOSS INSTRUMENTS, LTD./STEALTH SURGICAL, LLC.
104 sommerfield drive
gordonsville VA 22942
MDR Report Key7062802
MDR Text Key93050617
Report Number7062802
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS6995, SS6994, SS6993, AND SS6996
Device Catalogue NumberSS6995,SS6994,SS6993,SS6996
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2017
Event Location Hospital
Date Report to Manufacturer11/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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