Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number FCS9
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Swelling (2091); Brain Injury (2219); Respiratory Failure (2484)
Event Date 06/16/2015
Event Type  Death  
Event Description
The patient was admitted to surgery for a thyroidectomy due to nontoxic multinodular goiter.During the procedure, the 3-4 mm vessels were verified to be completely sealed.There were no complications or delays during the initial surgical procedure, and the patient was admitted to an inpatient unit.Approximately twelve hours later, the patient began having complications including swelling of the neck.The patient returned to surgery shortly after where the physician noted that the vessels that were sealed were open and pumping.The vessels could not be resealed; they were sutured.Blood loss was reported to be >3l.Post op, the patient was sent to critical care and died four days later.The patient had severe brain injury and respiratory failure from the hemorrhage/code.
 
Manufacturer Narrative
A supplemental will be submitted once the investigation is complete.As the lot number was not reported and the device was not returned for evaluation, it cannot be confirmed that the fcs9 is a stryker sustainability solutions device.Device discarded by the facility.
 
Manufacturer Narrative
Additional information: the investigation has been completed.The device was not returned for evaluation and the lot number was not recorded by the facility.Therefore, it could not be confirmed that the device was reprocessed by stryker sustainability solutions.Evaluation summary: visual inspection and functional testing were unable to be performed and the device history record (dhr) was unable to be reviewed, as the device was not returned.However, a review of all device history records for fcs9 devices shipped to the facility was performed to confirm the devices met all inspection and testing requirements prior to distribution.The review did not identify deviations or recent changes to the process or product related to the reported failure mode.Conclusion: as the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.The physician stated that the seal was verified to be complete with no patient bleeding or surrounding tissue damage after use.Therefore, it is unlikely that the fcs9 device was related to the reported event as a product failure would prevent the device from performing a complete seal or cause tissue damage that would be noticeable by the physician during the procedure.
 
Event Description
The patient was admitted to surgery for a thyroidectomy due to nontoxic multinodular goiter.During the procedure, the 3-4 mm vessels were verified to be completely sealed.There were no complications or delays during the initial surgical procedure, and the patient was admitted to an inpatient unit.Approximately twelve hours later, the patient began having complications including swelling of the neck.The patient returned to surgery shortly after where the physician noted that the vessels that were sealed were open and pumping.The vessels could not be resealed; they were sutured.Blood loss was reported to be >3l.Post op, the patient was sent to critical care and died four days later.The patient had severe brain injury and respiratory failure from the hemorrhage/code.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NA
Type of Device
SCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key4937382
MDR Text Key6434066
Report Number0001056128-2015-00066
Device Sequence Number1
Product Code NLQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberFCS9
Device Catalogue NumberFCS9RR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/25/2015
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? Yes
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age56 YR
Patient Weight67
-
-