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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C

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STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C Back to Search Results
Catalog Number 0502904030
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Information (3190)
Event Date 10/17/2017
Event Type  Injury  
Manufacturer Narrative
Alleged failure: burned. Confirmed failure: outer tube damaged (bent, dented),moisture ingression at distal end. Probable root cause: too much light from light source. Light source left on and scope/adapter left on or in patient. Reflected laser energy to the scope when used with laser equipment. Electrical discharge or coupled hf current when used with hf surgical equipment. The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence. (b)(4). The device manufacturer date is not known.
 
Event Description
An event description of "burned" was reported. It is unclear as to whether a patient or user was burned, or if there was a problem with the product. Several attempts were made to obtain additional information, however, no response was received.
 
Manufacturer Narrative
(b)(4). 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.
 
Event Description
An event description of "burned" was reported. It is unclear as to whether a patient or user was burned, or if there was a problem with the product. Several attempts were made to obtain additional information, however, no response was received.
 
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Brand NamePKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C
Type of DeviceARTHROSCOPE
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 Key7031640
MDR Text Key258336831
Report Number0002936485-2017-01104
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0502904030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
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

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