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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG KNIFE LIGHT 10/PK SURGICAL LAMP

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STRYKER LEIBINGER FREIBURG KNIFE LIGHT 10/PK SURGICAL LAMP Back to Search Results
Catalog Number 3300-001-000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2017
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.
 
Manufacturer Narrative
The reported event that during an in-coming inspection at the distribution center, a foreign material (hair) was found inside the sterile blister of a ¿knife light 10/pk¿, could be confirmed, based on the provided image documentation. The actual ¿knife light 10/pk¿ was not returned. However, a visual inspection, through the provided image documentation, was performed and revealed that the device was intact inside the sterile packaging, but a foreign material (piece of hair) was identified inside the packaging. Due to this deviation, an nc was opened. Based on the investigation, the root cause was attributed to a manufacturing related issue. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
 
Event Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.
 
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Brand NameKNIFE LIGHT 10/PK
Type of DeviceSURGICAL LAMP
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER ENDOSCOPY-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6531845
MDR Text Key74169374
Report Number0008031020-2017-00271
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
PMA/PMN Number
K961122
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 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2018
Device Catalogue Number3300-001-000
Device Lot Number16344FE2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/28/2017 Patient Sequence Number: 1
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