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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 Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2017
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Product was discarded by the hospital.
 
Event Description
After opening sterile package, the user tried to turn on the light, but the light did not turn on. And there is a crack around the guard area.
 
Manufacturer Narrative
The reported event that knife light 10/pk was alleged of 'not functional' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. Note, as stated in the ifu (3300-001-702): ''2 warnings and precautions ¿ single use devices cannot be reused, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications and may result in patient and/or user injury. Please refer to the device label to identify single or multiple use and/ or cleaning and re sterilization release. ¿ the knifelight must only be used by physicians who have specific anatomical and surgical skills and are experienced in hand surgery. ¿ it is the responsibility of the attending surgeon to determine the appropriateness of this instrument and specific technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique. ¿ read and understand these instructions. Familiarization with knifelight prior to use is important. [¿] ¿ do not pull the back cap. Rotate to illuminate knifelight. The back cap is designed to be pulled off (with force) for the purpose of battery removal. '' [original statement(s)] 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
After opening sterile package, the user tried to turn on the light, but the light did not turn on. And there is crack on around guard area.
 
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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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6411302
MDR Text Key70420098
Report Number0008010177-2017-00053
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number3300-001-000
Device Lot Number16231FE2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
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: 03/16/2017 Patient Sequence Number: 1
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