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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN UNKNOWN KNIFELIGHT ENDOLUMINAL KNIFE INSTRUMENT

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STRYKER GMBH UNKNOWN UNKNOWN KNIFELIGHT ENDOLUMINAL KNIFE INSTRUMENT Back to Search Results
Catalog Number UNK_SEL
Device Problem Off-Label Use (1494)
Patient Problem Scarring (2061)
Event Date 09/01/2009
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The manufacturer became aware of a study from ¿(b)(6)¿. The study was published on september 2009, within that publication, 8 cases involving knifelight endoluminal knife were reported, which were found to be off-label. The study states, ¿the only treatment is the fasciotomy of the compartments and the gold standard procedure is still the open-invasive surgery. The authors describe a new mini-invasive surgical procedure to perform a 4-compartment fasciotomy of the forearm and expose their results. ¿ it was not possible to ascertain specific catalog or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported previously, therefore 8 complaints were initiated retrospectively for the off-label use mentioned in the report. This product inquiry addresses hypertrophic proximal volar scar.
 
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Brand NameUNKNOWN UNKNOWN KNIFELIGHT ENDOLUMINAL KNIFE
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8117500
MDR Text Key128861074
Report Number0008031020-2018-01011
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
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 Received10/31/2018
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: 11/29/2018 Patient Sequence Number: 1
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