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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 08/01/2000
Event Type  malfunction  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence. A review of the labeling did not indicate any abnormalities. If any further information is provided, the investigation report will be updated. Device evaluated by mfr: device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6) university school of medicine, (b)(6). The title of this report is ¿carpal tunnel release using a short palmar incision and a new knife¿ which was published in august 2000 and is associated with the stryker knifelight. Within that publication, intraoperative/post-operative complications/ adverse events were reported. It was not possible to ascertain specific device information from the article; 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, 5 complaints were initiated retrospectively for different adverse events mentioned in the study. This product inquiry addresses knifelight breakage intraoperatively. The study states: ¿in one patient, in the earlier part of the study, the preliminary 3 to 4 mm scalpel incision in the flexor retinaculum was not performed: the increased force required to cut the retinaculum broke the long skid of the knife, which was retrieved easily. ¿.
 
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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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8803343
MDR Text Key151711873
Report Number0008031020-2019-00841
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
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 Received06/21/2019
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

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