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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.8MM CANNULA, 2 FIXED STOPCOCKS; ACCESSORIES,ARTHROSCOPIC

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STRYKER ENDOSCOPY-SAN JOSE 5.8MM CANNULA, 2 FIXED STOPCOCKS; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 0747031560
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2016
Event Type  malfunction  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported during surgery the device broke off inside the patient.All the broken pieces were retrieved from the patient.The procedure was completed successfully with no adverse consequences to the patient.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: valve broke.Probable root cause: poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Use error.The failure mode will be monitored for future reoccurrence.Mfg date: manufacture date is not known.(b)(4).
 
Event Description
It was reported during surgery the device broke off inside the patient.All the broken pieces were retrieved from the patient.The procedure was completed successfully with no adverse consequences to the patient.
 
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Brand Name
5.8MM CANNULA, 2 FIXED STOPCOCKS
Type of Device
ACCESSORIES,ARTHROSCOPIC
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
ashley lower
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6301455
MDR Text Key66763580
Report Number0002936485-2017-00113
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 06/15/2017
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 Number0747031560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/10/2017
Initial Date FDA Received02/03/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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