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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 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
When the surgeon tried to cut ligament with the knife light, the tip of it was broken. Therefore, it was changed to the new one and the operation was successful.
 
Manufacturer Narrative
The reported event that knife light 10/pk was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. It was reported that the knifelight was used to cut ligaments, which is a clear contraindication of what is stated in the instructions for use, therefore it is very likely that the root cause is user related. However, 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): ¿do not use the knifelight as a retracting device to pry or separate muscle or ligaments. Using the device in this manner may cause the tip of the knifelight to break off in the surgical site and may result in injury. ¿ [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
When the surgeon tried to cut ligament with the knife light, the tip of it was broken. Therefore, it was changed the new same one and the operation was succeeded.
 
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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 Key6411142
MDR Text Key70420903
Report Number0008010177-2017-00052
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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