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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN KNIFELIGHT INSTRUMENT

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STRYKER GMBH UNKNOWN KNIFELIGHT INSTRUMENT Back to Search Results
Catalog Number UNK_SEL
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2005
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. 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. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6) university of medical sciences, (b)(6). The title of this report is ¿mini open carpal tunnel release: a new technique using knifelight system. ¿ which is associated with the stryker ¿knifelight¿ system. Within that publication, intraoperatively/post-operative complications/ adverse events were reported which occurred from september 2005 to april 2009. It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 9 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses broken surgical knife tip. 1 out of 2 cases. The report states: ¿in 2 cases of the surgical operations, the tip of the surgical knife broke during the operation. The broken piece was removed and classic octr was performed on the patients and then they were excluded from the study. ¿.
 
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Brand NameUNKNOWN KNIFELIGHT
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER ENDOSCOPY-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9247958
MDR Text Key178362401
Report Number0008031020-2019-01560
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeIR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
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 Received10/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/28/2019 Patient Sequence Number: 1
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