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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE RIGHT ANGLE ADAPTER FOR AUTOCLAVABLE SCOPES; N/A
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STRYKER ENDOSCOPY-SAN JOSE RIGHT ANGLE ADAPTER FOR AUTOCLAVABLE SCOPES; N/A Back to Search Results
Catalog Number 0331000400
Device Problem Insufficient Information (3190)
Patient Problem Burn, Thermal (2530)
Event Date 03/12/2014
Event Type  Injury  
Event Description
It was reported that after the procedure, a slight burn was observed on the skin of the patient.It was further reported that the adapter was placed on the drape that was on the patient.A scope along with a lightsource were used together and the setting on the lightsource was stated to be set at 80.
 
Event Description
It was reported that after the procedure, a slight burn was observed on the skin of the patient.It was further reported that the adapter was placed on the drape that was on the patient.A scope along with a lightsource were used together and the setting on the lightsource was stated to be set at 80.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.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, a full evaluation will be conducted, 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: user misuse/mishandling (leaving the scope on the patient while the light was on).In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.
 
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Brand Name
RIGHT ANGLE ADAPTER FOR AUTOCLAVABLE SCOPES
Type of Device
N/A
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 Key3730643
MDR Text Key4271721
Report Number0002936485-2014-00191
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0331000400
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/12/2014
Initial Date FDA Received04/07/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/27/2014
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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