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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 Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 05/02/2017
Event Type  Injury  
Manufacturer Narrative
Scope was sent in as a repair with only please evaluate no complaint attached. Scope was decontaminated, evaluated and sent out prior to notification that a bacterial testing should done as there have been 3 patient infections tied back to this specific serial number at the acct, thus the reported failure was not confirmed. Alleged failure: 3 patient infections tied back to this specific serial number at the acct. Confirmed failure: outer tube damaged (bent, dented). Probable root cause: improper storage conditions, improper handling, sterilization process not effective, improper reprocessing. The device manufacturer date is not known. The product was returned for investigation and the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. (b)(4).
 
Event Description
It was reported the device contributed to patient infection.
 
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
It was reported the device contributed to patient infection.
 
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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
sandhya jaishankar
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6710952
MDR Text Key254846929
Report Number0002936485-2017-00671
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0502904030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/13/2017 Patient Sequence Number: 1
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