NA
Report
- Report Number
- 0001056128-2021-00062
- Event Type
- Death
- Date Received
- October 13, 2021
- Date of Event
- September 2, 2021
- Report Date
- October 13, 2021
- Manufacturer
- STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
- Product Code
- NUJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE REPORTED EVENT WAS SUBMITTED THROUGH A MEDWATCH FORM AND NO FOLLOW UP IS POSSIBLE AS NO FACILITY OR CONTACT INFORMATION, CATALOG NUMBER, LOT NUMBER OR SERIAL NUMBER WERE PROVIDED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, INSPECTION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER AND/OR SERIAL NUMBER WAS NOT REPORTED. THE REPORTED EVENT COULD BE ATTRIBUTED TO THE FOLLOWING: ANCILLARY EQUIPMENT FAILURE. TRIGGER BUTTON (ACTIVATION BUTTON) NOT ENGAGED THROUGHOUT THE ENTIRE SEAL CYCLE. DEVICE ACTIVATED IN CONTACT WITH POOLING FLUID. DEVICE USED ON VESSELS THICKER THAN 7 MM. DEVICE NOT CLEANED WHILE IN USE PER IFU GUIDANCE. THE INSTRUCTIONS FOR USE (IFU) STATE: LF4418: REPROCESSED LIGASURE IMPACT WITHOUT NANO-COATING, LARGE JAW, OPEN SEALER/DIVIDERS (MODEL LF4418) INSTRUCTIONS FOR USE (IFU): USE CAUTION DURING SURGICAL CASES IN WHICH PATIENTS EXHIBIT CERTAIN TYPES OF VASCULAR PATHOLOGY (ATHEROSCLEROSIS, ANEURYSMAL VESSELS, ETC.). FOR BEST RESULTS, APPLY THE SEAL TO UNAFFECTED VASCULATURE. DO NOT USE THIS INSTRUMENT ON VESSELS IN EXCESS OF 7 MM IN DIAMETER. PLACE THE VESSEL OR TISSUE IN THE CENTER OF THE JAWS. TO AVOID INCOMPLETE SEALING, DO NOT GRASP TISSUE BEYOND THE ELECTRODE SURFACE; DO NOT PLACE TISSUE IN THE JAW HINGE. CONTACT BETWEEN AN ACTIVE INSTRUMENT ELECTRODE AND ANY METAL OBJECT (HEMOSTATS, STAPLES, CLIPS, RETRACTORS, ETC.) MAY INCREASE CURRENT FLOW AND MAY RESULT IN UNINTENDED SURGICAL EFFECTS, SUCH AS AN EFFECT AT AN UNINTENDED SITE OR INSUFFICIENT ENERGY DEPOSITION. ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING TO ENSURE PROPER FUNCTION. DO NOT ATTEMPT TO SEAL OVER CLIPS OR STAPLES AS INCOMPLETE SEALS/DAMAGE TO THE CUTTING BLADE WILL OCCUR. CONTACT BETWEEN AN ACTIVE ELECTRODE AND ANY METAL OBJECTS MAY RESULT IN ALTERNATE SITE BURNS OR INCOMPLETE SEALS. A CONTINUOUS TONE SOUNDS TO INDICATE THE ACTIVATION OF RF ENERGY. WHEN THE ACTIVATION CYCLE IS COMPLETE, A TWO-PULSED SEAL-CYCLE-COMPLETE TONE SOUNDS AND RF OUTPUT CEASES. THE SURGEON MAY INSPECT THE SEAL BEFORE CUTTING THE VESSEL OR TISSUE. AFTER INSPECTING THE SEAL, THE SURGEON SHOULD CREATE A SECOND SEAL ADJACENT TO THE FIRST SEAL BEFORE CUTTING, AS DESCRIBED BELOW. KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A STERILE, WET GAUZE PAD AS NEEDED. A TONE WITH MULTIPLE PULSES INDICATES THAT THE SEAL CYCLE WAS NOT COMPLETED. DO NOT CUT TISSUE UNTIL YOU HAVE VERIFIED THAT THERE IS AN ADEQUATE SEAL. USE CAUTION DURING SURGICAL CASES IN WHICH PATIENTS EXHIBIT INCOMPRESSIBLE TISSUE. THERE MAY BE LIMITATIONS ASSOCIATED WITH EFFECTIVE USE OF THE DEVICE IN THESE SITUATIONS. LF17XX: IFU REVIEW; REPROCESSED LIGASURE MARYLAND JAW SEALER/DIVIDER INSTRUCTIONS FOR USE (IFU): USE CAUTION DURING SURGICAL CASES IN WHICH PATIENTS EXHIBIT CERTAIN TYPES OF VASCULAR PATHOLOGY (ATHEROSCLEROSIS, ANEURYSMAL VESSELS, ETC.). FOR BEST RESULTS, APPLY THE SEAL TO UNAFFECTED VASCULATURE. IF THE GENERATOR PROVIDES MULTIPLE POWER SETTINGS, USE THE LOWEST POWER NEEDED TO ACHIEVE THE INTENDED EFFECT. DO NOT USE THIS INSTRUMENT ON VESSELS IN EXCESS OF 7 MM IN DIAMETER. IF THE INSTRUMENT SHAFT IS VISIBLY BENT, DISCARD AND REPLACE THE INSTRUMENT. DO NOT PLACE THE VESSEL AND/OR TISSUE IN THE JAW HINGE. PLACE THE VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING TO ENSURE PROPER FUNCTION. USE CAUTION WHEN GRASPING, MANIPULATING, SEALING, AND DIVIDING LARGE TISSUE BUNDLES. DO NOT BEND INSTRUMENT SHAFT. DO NOT ATTEMPT TO SEAL OVER CLIPS OR STAPLES AS INCOMPLETE SEALS/DAMAGE TO THE CUTTING BLADE WILL OCCUR. CONTACT BETWEEN AN ACTIVE ELECTRODE AND ANY METAL OBJECTS MAY RESULT IN ALTERNATE SITE BURNS OR INCOMPLETE SEALS. DO NOT OVERFILL THE JAWS OF THE INSTRUMENT WITH TISSUE, AS THIS MAY REDUCE DEVICE PERFORMANCE. KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. THE LEVER MUST BE CONTINUALLY HELD WITH THE ACTIVATION BUTTON FULLY DEPRESSED UNTIL THE SEAL CYCLE IS COMPLETE. THE LEVER DOES NOT LATCH INTO THE ACTIVATION POSITION. A CONTINUOUS TONE SOUNDS TO INDICATE THE ACTIVATION OF RF ENERGY. WHEN THE ACTIVATION CYCLE IS COMPLETE, A TWO-PULSED SEAL-CYCLE-COMPLETE TONE SOUNDS AND RF OUTPUT CEASES. NOTICE ¿ THE SURGEON MAY INSPECT THE SEAL BEFORE CUTTING THE VESSEL OR TISSUE. AFTER INSPECTING THE SEAL, THE SURGEON SHOULD CREATE A SECOND SEAL ADJACENT TO THE FIRST SEAL BEFORE CUTTING, AS DESCRIBED BELOW. A TONE WITH MULTIPLE PULSES INDICATES THAT THE SEAL CYCLE WAS NOT COMPLETED. REFER TO THE TROUBLESHOOTING SECTION FOR POSSIBLE CAUSES AND CORRECTIVE ACTIONS. DO NOT CUT TISSUE UNTIL YOU HAVE VERIFIED THAT THERE IS AN ADEQUATE SEAL. TO SEAL ADJACENT TISSUE, OVERLAP THE EDGE OF THE EXISTING SEAL. THE SECOND SEAL SHOULD BE DISTAL TO THE FIRST SEAL TO INCREASE SEAL MARGIN. ACTIVATING ENERGY DELIVERY WITH A FOOTSWITCH WHEN THE ACTIVATION BUTTON IS NOT FULLY DEPRESSED MAY RESULT IN IMPROPER SEALING AND INCREASE THERMAL SPREAD TO TISSUE OUTSIDE THE SURGICAL SITE. PROPER PRESSURE IS BEING APPLIED TO THE TISSUE WHEN THE LEVER KEEPS THE ACTIVATION BUTTON FULLY DEPRESSED. ENERGY-BASED DEVICES, SUCH AS ESU PENCILS OR ULTRASONIC SCALPELS THAT ARE ASSOCIATED WITH THERMAL SPREAD SHOULD NOT BE USED TO TRANSECT SEALS. FAILURE TO MAINTAIN STEADY PRESSURE ON THE LEVER WHILE CUTTING CAN RESULT IN INADVERTENT REACTIVATION OF ENERGY. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. REMOVE ANY EMBEDDED TISSUE FROM BLADE TRACK AND JAW HINGE AREA. LF18XX: INSTRUCTIONS FOR USE REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER WITHOUT NANO-COATING (MODEL LF1837) IFU: DO NOT PLACE THE VESSEL AND/OR TISSUE IN THE JAW HINGE. PLACE THE VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. DO NOT USE THIS INSTRUMENT ON VESSELS LARGER THAN 7 MM IN DIAMETER. IF THE INSTRUMENT SHAFT IS VISIBLY BENT, DISCARD AND REPLACE THE INSTRUMENT. A BENT SHAFT MAY PREVENT THE INSTRUMENT FROM SEALING OR CUTTING PROPERLY. ELIMINATE TENSION ON THE TISSUE WHEN SEALING AND CUTTING TO ENSURE PROPER FUNCTION. USE CAUTION WHEN GRASPING, MANIPULATING, SEALING, AND DIVIDING LARGE TISSUE BUNDLES. DO NOT ATTEMPT TO SEAL OR CUT OVER CLIPS OR STAPLES AS INCOMPLETE SEALS WILL BE FORMED. CONTACT BETWEEN AN ACTIVE ELECTRODE AND ANY METAL OBJECTS MAY RESULT IN ALTERNATE SITE BURNS OR INCOMPLETE SEALS. DO NOT ACTIVATE THE LIGASURE SYSTEM IN AN OPEN-CIRCUIT CONDITION. ACTIVATE THE SYSTEM ONLY WHEN THE INSTRUMENT IS IN DIRECT CONTACT WITH THE TARGET TISSUE TO LESSEN THE POSSIBILITY OF UNINTENDED BURNS. A CONTINUOUS TONE SOUNDS TO INDICATE THE ACTIVATION OF RF ENERGY. WHEN THE ACTIVATION CYCLE IS COMPLETE, A TWO-PULSED SEAL-CYCLE-COMPLETE TONE SOUNDS AND RF OUTPUT CEASES. PRIOR TO CUTTING THE SEAL, INSPECT THE VESSEL OR TISSUE TO ENSURE PROPER SEALING. KEEP THE INSTRUMENT JAWS (1) CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. IN CASE THE INSTRUMENT IS ACCIDENTLY DROPPED ON THE FLOOR, TURN OFF THE GENERATOR AND UNPLUG THE INSTRUMENT PRIOR TO DISCARDING. INSPECT THE INSTRUMENT AND CORDS FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGE BEFORE USE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR SURGICAL TEAM OR CAUSE DAMAGE TO THE INSTRUMENT. IF DAMAGED, DO NOT USE. DO NOT TURN THE ROTATION WHEEL WHEN THE LEVER IS LATCHED. PRODUCT DAMAGE MAY OCCUR. TURN THE ROTATION WHEEL ON THE INSTRUMENT UNTIL THE JAWS ARE IN THE REQUIRED POSITION. LF19XX: IFU REVIEW; INSTRUCTIONS FOR USE REPROCESSED LIGASURE MARYLAND JAW SEALER/DIVIDER WITHOUT NANO-COATING (MODEL LF1923, LF1937, AND LF1944). LF19XX DEVICES ARE COMPATIBLE WITH FORCETRIAD SW (B)(4). USE CAUTION DURING SURGICAL CASES IN WHICH PATIENTS EXHIBIT CERTAIN TYPES OF VASCULAR PATHOLOGY (ATHEROSCLEROSIS, ANEURYSMAL VESSELS, ETC.). FOR BEST RESULTS, APPLY THE SEAL TO UNAFFECTED VASCULATURE. IF THE GENERATOR PROVIDES MULTIPLE POWER SETTINGS, USE THE LOWEST POWER NEEDED TO ACHIEVE THE INTENDED EFFECT. DO NOT USE THIS INSTRUMENT ON VESSELS IN EXCESS OF 7 MM IN DIAMETER. IF THE INSTRUMENT SHAFT IS VISIBLY BENT, DISCARD AND REPLACE THE INSTRUMENT. DO NOT PLACE THE VESSEL AND/OR TISSUE IN THE JAW HINGE. PLACE THE VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING TO ENSURE PROPER FUNCTION. USE CAUTION WHEN GRASPING, MANIPULATING, SEALING, AND DIVIDING LARGE TISSUE BUNDLES. DO NOT BEND INSTRUMENT SHAFT. DO NOT ATTEMPT TO SEAL OVER CLIPS OR STAPLES AS INCOMPLETE SEALS/DAMAGE TO THE CUTTING BLADE WILL OCCUR. CONTACT BETWEEN AN ACTIVE ELECTRODE AND ANY METAL OBJECTS MAY RESULT IN ALTERNATE SITE BURNS OR INCOMPLETE SEALS. DO NOT OVERFILL THE JAWS OF THE INSTRUMENT WITH TISSUE, AS THIS MAY REDUCE DEVICE PERFORMANCE. KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. THE LEVER MUST BE CONTINUALLY HELD WITH THE ACTIVATION BUTTON FULLY DEPRESSED UNTIL THE SEAL CYCLE IS COMPLETE. THE LEVER DOES NOT LATCH INTO THE ACTIVATION POSITION. A CONTINUOUS TONE SOUNDS TO INDICATE THE ACTIVATION OF RF ENERGY. WHEN THE ACTIVATION CYCLE IS COMPLETE, A TWO-PULSED SEAL-CYCLE-COMPLETE TONE SOUNDS AND RF OUTPUT CEASES. NOTICE ¿ THE SURGEON MAY INSPECT THE SEAL BEFORE CUTTING THE VESSEL OR TISSUE. AFTER INSPECTING THE SEAL, THE SURGEON SHOULD CREATE A SECOND SEAL ADJACENT TO THE FIRST SEAL BEFORE CUTTING, AS DESCRIBED BELOW. A TONE WITH MULTIPLE PULSES INDICATES THAT THE SEAL CYCLE WAS NOT COMPLETED. REFER TO THE TROUBLESHOOTING SECTION FOR POSSIBLE CAUSES AND CORRECTIVE ACTIONS. DO NOT CUT TISSUE UNTIL YOU HAVE VERIFIED THAT THERE IS AN ADEQUATE SEAL. TO SEAL ADJACENT TISSUE, OVERLAP THE EDGE OF THE EXISTING SEAL. THE SECOND SEAL SHOULD BE DISTAL TO THE FIRST SEAL TO INCREASE SEAL MARGIN. ACTIVATING ENERGY DELIVERY WITH A FOOTSWITCH WHEN THE ACTIVATION BUTTON IS NOT FULLY DEPRESSED MAY RESULT IN IMPROPER SEALING AND INCREASE THERMAL SPREAD TO TISSUE OUTSIDE THE SURGICAL SITE. PROPER PRESSURE IS BEING APPLIED TO THE TISSUE WHEN THE LEVER KEEPS THE ACTIVATION BUTTON FULLY DEPRESSED. ENERGY-BASED DEVICES, SUCH AS ESU PENCILS OR ULTRASONIC SCALPELS THAT ARE ASSOCIATED WITH THERMAL SPREAD SHOULD NOT BE USED TO TRANSECT SEALS. FAILURE TO MAINTAIN STEADY PRESSURE ON THE LEVER WHILE CUTTING CAN RESULT IN INADVERTENT REACTIVATION OF ENERGY. REMOVE ANY EMBEDDED TISSUE FROM BLADE TRACK AND JAW HINGE AREA. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED.
IT WAS REPORTED THE IMPACT LIGASURE DEVICE "FAILED TO APPROPRIATELY SEAL/LIGATE AND DIVIDE BLOOD VESSELS," RESULTING IN POST OPERATIVE HEMORRHAGE. THE PATIENT PROCEEDED ON TO END ORGAN ISCHEMIA AND MULTI SYSTEM ORGAN FAILURE AND SUCCUMBED TO THIS INSULT. THE REPORTED EVENT WAS SUBMITTED THROUGH A MEDWATCH FORM AND NO FOLLOW UP IS POSSIBLE AS NO FACILITY OR CONTACT INFORMATION, CATALOG NUMBER, LOT NUMBER, OR SERIAL NUMBER WERE PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525548 | NA | ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R | NUJ | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |