PENCIL, H2K, PUSHBUTTON
Report
- Report Number
- 3007305485-2023-00080
- Event Type
- Malfunction
- Date Received
- April 13, 2023
- Date of Event
- March 27, 2023
- Report Date
- June 5, 2023
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K001159
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 501
Narratives
THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.
THE DEVICE HAS NOT BEEN RETURNED TO DATE AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVEN CANNOT BE VERIFIED. IF THE DEVICE IS RETURNED, AT A LATER DATE, THE INVESTIGATION MAY BE UPDATED AND REANALYZED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. IN ADDITION, PER THE HYFRECATOR IFU, 7-900-OM-ENG, SOME MATERIALS, FOR EXAMPLE, COTTON, WOOL AND GAUZE, WHEN SATURATED WITH OXYGEN MAY BE IGNITED BY SPARKS PRODUCED IN NORMAL USE OF THE HYFRECATOR® 2000. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
DEVICE WAS RETURNED FOR EVALUATION. UPDATE: EVALUATED UNIT PER IP, FOUND ONLY TWO POINTS ARE OUT OF SPEC. CHECKED SPARK WITH CUSTOMER'S UNIT PENCIL WITH LOW, MIDDLE AND HI POWER; COULD NOT FIND DIFFERENCE WITH ANY OTHER UNIT. UNIT WAS BUILT IN 2017, NO PREMATURE PROBLEM. UNIT DOES NOT HAVE POWER INPUT BRACKET. MANUFACTURER NARRATIVE: A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 REPORTS, REGARDING 2 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. IN ADDITION, PER THE HYFRECATOR IFU, 7-900-OM-ENG, SOME MATERIALS, FOR EXAMPLE, COTTON, WOOL AND GAUZE, WHEN SATURATED WITH OXYGEN MAY BE IGNITED BY SPARKS PRODUCED IN NORMAL USE OF THE HYFRECATOR® 2000. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-5 PENCIL, H2K, PUSHBUTTON WAS BEING USED ON (B)(6) 2023, DURING A SKIN TAG REMOVAL FROM VULVA PROCEDURE. WHEN CAUTERIZING, USING AT HIGH(10), DERMATOLOGIST NOTICED A SPARK AND THEN AN ARC WAS SEEN WHICH CAUSED THE NEARBY GAUZE TO IGNITE. AS A PRECAUTIONARY MEASURE WE WOULD LIKE THIS SERVICED. THIS HAS ONLY HAPPENED ONCE. JUST BEFORE THE INCIDENT THE PATIENT FELT SOME DISCOMFORT, AFTER THE INCIDENT THE DERMATOLOGIST ASSESSED THE PATIENT. NOTHING VISIBLE, BUT COOLED THE AREA. PATIENT WAS INVITED BACK TO BE ASSESSED, BUT HAS STATED THEY ARE FINE AND NO INJURY. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PROCEDURE WAS COMPLETED. "THERE WAS NO INJURY TO THE STAFF MEMBERS OR PATIENT, (THERE WAS A CONSULTANT DERMATOLOGIST AND HEALTHCARE ASSISTANT PRESENT). PATIENT FELT UNCOMFORTABLE AND FELT HEAT, BUT AREA WAS COOLED AND NO INJURY SEEN." THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE STAFF MEMBER. "STAFF MEMBER AND HCA BOTH FINE". THE 7-900-230, HYFRECATOR 2000, 230V WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-5 PENCIL, H2K, PUSHBUTTON WAS BEING USED ON (B)(6) 2023 DURING A SKIN TAG REMOVAL FROM VULVA PROCEDURE AND "WHEN CAUTERIZING, USING AT HIGH(10), DERMATOLOGIST NOTICED A SPARK AND THEN AN ARC WAS SEEN WHICH CAUSED THE NEARBY GAUZE TO IGNITE, AS A PRECAUTIONARY MEASURE WE WOULD LIKE THIS SERVICED. THIS HAS ONLY HAPPENED ONCE. JUST BEFORE THE INCIDENT THE PATIENT FELT SOME DISCOMFORT, AFTER THE INCIDENT THE DERMATOLOGIST ASSESSED THE PATIENT, NOTHING VISIBLE, BUT COOLED THE AREA. PATIENT WAS INVITED BACK TO BE ASSESSED, BUT HAS STATED THEY ARE FINE AND NO INJURY." THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PROCEDURE WAS COMPLETED. "THERE WAS NO INJURY TO THE STAFF MEMBERS OR PATIENT, (THERE WAS A CONSULTANT DERMATOLOGIST AND HEALTHCARE ASSISTANT PRESENT). PATIENT FELT UNCOMFORTABLE AND FELT HEAT, BUT AREA WAS COOLED AND NO INJURY SEEN." THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE STAFF MEMBER. "STAFF MEMBER AND HCA BOTH FINE". THE 7-900-230, HYFRECATOR 2000, 230V WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-5 PENCIL, H2K, PUSHBUTTON WAS BEING USED ON (B)(6) 2023 DURING A SKIN TAG REMOVAL FROM VULVA PROCEDURE AND ¿WHEN CAUTERIZING, USING AT HIGH(10), DERMATOLOGIST NOTICED A SPARK AND THEN AN ARC WAS SEEN WHICH CAUSED THE NEARBY GAUZE TO IGNITE, AS A PRECAUTIONARY MEASURE WE WOULD LIKE THIS SERVICED. THIS HAS ONLY HAPPENED ONCE. JUST BEFORE THE INCIDENT THE PATIENT FELT SOME DISCOMFORT, AFTER THE INCIDENT THE DERMATOLOGIST ASSESSED THE PATIENT, NOTHING VISIBLE, BUT COOLED THE AREA. PATIENT WAS INVITED BACK TO BE ASSESSED, BUT HAS STATED THEY ARE FINE AND NO INJURY.¿ THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PROCEDURE WAS COMPLETED. "THERE WAS NO INJURY TO THE STAFF MEMBERS OR PATIENT, (THERE WAS A CONSULTANT DERMATOLOGIST AND HEALTHCARE ASSISTANT PRESENT). PATIENT FELT UNCOMFORTABLE AND FELT HEAT, BUT AREA WAS COOLED AND NO INJURY SEEN." THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE STAFF MEMBER. "STAFF MEMBER AND HCA BOTH FINE". THE 7-900-230, HYFRECATOR 2000, 230V WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1455890 | PENCIL, H2K, PUSHBUTTON | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 7-900-230, HYFRECATOR 2000| 7-900-230, HYFRECATOR 2000| 7-900-230, HYFRECATOR 2000 |