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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITHOUT TIP (6BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITHOUT TIP (6BX); LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250070500
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2015
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: 1.Material/design error, 2.Manufacturing/assembly error, 3.Improper cleaning/sterilization, 4.Excessive user force, 5.Severe shipping conditions, 6.Disposable tip rubbing against lid, 7.User misuse.
 
Event Description
It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
 
Manufacturer Narrative
(b)(4).The product was returned and the failure mode was confirmed.The two tubesets were visually inspected for damages, and the distal tips of the insertion spikes are bent.The probable root causes could be: material/design error.Manufacturing/assembly error.Improper cleaning/sterilization.Excessive user force.Severe shipping conditions.Disposable tip rubbing against product.User misuse.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
 
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Brand Name
STRYKEFLOW2 WITHOUT TIP (6BX)
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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
valerie estrada
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key5115600
MDR Text Key27235335
Report Number0002936485-2015-00865
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Followup,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0250070500
Device Lot Number15111FG2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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