MAUDE Adverse Event Report: STRYKER GMBH KNIFE LIGHT 10/PK; LAMP, SURGICAL

Model Number	3300-001-000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "fluorescent substances came out of the product.During the carpal tunnel syndrome op, the fluorescent substances came out of the product.The patient's skin was stained with the fluorescent substances.The surgeon wiped out the substances and replace the device with a new one.The procedure was completed successfully.No adverse consequences is reported.A 3 minute surgical delay occurred to replace the device and wipe off the substances.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device was returned and was identified as lot# 21357fe2, as reported.The light feature of the device was tested, and it turns on as needed.Since it was reported that a fluorescent substance came out of the product during surgery, it was decided to take apart the different pieces of the device.No sub component looks like it was leaking.No leak could be confirmed from the batteries either.No corrosion traces and no deformation of the opposite sides of the batteries could be found.The tube of the device does not show any deposits that could prove the presence of a substance leaking.Based on investigation, the root cause of the reported event could not be linked to the knifelight.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 material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "fluorescent substances came out of the product.During the carpal tunnel syndrome op, the fluorescent substances came out of the product.The patient's skin was stained with the fluorescent substances.The surgeon wiped out the substances and replace the device with a new one.The procedure was completed successfully.No adverse consequences is reported.A 3 minute surgical delay occurred to replace the device and wipe off the substances.".

• Brand Name: KNIFE LIGHT 10/PK
• Common Device Name: LAMP, SURGICAL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15584308
• Report Number: 0008031020-2022-00541
• Device Sequence Number: 2809592
• Product Code: FTD
• UDI-Device Identifier: 34546540060113
• UDI-Public: 34546540060113
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K961122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2023
• Device Model Number: 3300-001-000
• Device Catalogue Number: 3300-001-000
• Device Lot Number: 21357FE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown