NA
Report
- Report Number
- 0001056128-2015-00066
- Event Type
- Death
- Date Received
- July 23, 2015
- Date of Event
- June 16, 2015
- Report Date
- June 26, 2015
- Manufacturer
- STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
- Product Code
- NLQ
- PMA / PMN Number
- K100537
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479436 | NA | SCALPEL, ULTRASONIC, REPROCESSED | NLQ | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND | FCS9 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |