N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9902222
- MDR report key
- 9902222
- Report number
- 1717344-2020-00358
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EDGE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | COVIDIEN MFG DC BOULDER | GEI | E1455 | E1455 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSULATOR OF THE TWO ELECTRODES BROKE AND FELL INTO THE PATIENT'S CAVITY. THE BROKEN PIECE WAS FULLY RETRIEVED, AND AN X-RAY WAS NOT PERFORMED TO LOCATE IT. A PICTURE OF THE ELECTRODES WAS SUBMITTED AND IT SHOWED THE BROKEN INSULATOR OF ONE OF THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY.
N
Patient 1
EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE PRODUCT IN THE PICTURE DID NOT MEET SPECIFICATION. VISUAL INSPECTION FOUND THE BLUE HEAT SHRINK TO HAVE BEEN SCRATCHED AND DAMAGED ALLOWING THE PTFE INSULATOR TO GET TORN AND FALL OFF. THE REPORTED CONDITION WAS CONFIRMED. INSPECTION FOUND THE BLUE INSULATION WAS SCRATCHED. THE PTFE INSULATOR CAME OFF. THE BLUE HEAT SHRINK INSULATION HOLDS THE PTFE IN PLACE AND DAMAGE TO THE INSULATION CAN CAUSE THE CLEAR INSULATION TO BE TORN. THE DAMAGE TO THE ELECTRODE INDICATES THE USER MISHANDLED THE ELECTRODES. IT ALSO MAY HAVE BEEN CLEANED WITH AN ABRASIVE MATERIAL. THIS CLEANING METHOD WOULD ALSO CONTRIBUTE TO THE INSULATOR DISENGAGING. THE DEVICE FAILED HIPOT TESTING AT THE SCRATCH SITES ON THE BLUE INSULATION. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE ATTRIBUTED TO USER HANDLING DAMAGE. THE INSTRUCTIONS FOR USE (IFU) STATES: THE ELECTRODE HAS A COATING TO REDUCE STICKING OF ESCHAR. CLEANING THE ELECTRODE WITH A SCRATCH PAD OR OTHER ABRASIVE OBJECT, SCRAPING WITH A SHARP OBJECT OR BENDING BEYOND 90 DEGREES MAY DAMAGE THE ELECTRODE. IF THE ELECTRODE IS DAMAGED, DISCARD IT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE INSULATOR OF THE TWO ELECTRODES BROKE AND FELL INTO THE PATIENT'S CAVITY. THE BROKEN PIECE WAS FULLY RETRIEVED, AND AN X-RAY WAS NOT PERFORMED TO LOCATE IT. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION DONE TO RETRIEVED THE DISENGAGED PIECE. THEY USED A THIRD ELECTRODE TO COMPLETE THE PROCEDURE. A PICTURE OF THE ELECTRODES WAS SUBMITTED AND IT SHOWED THE BROKEN INSULATOR OF ONE OF THE REPORTED PRODUCT. THERE WAS NO PATIENT INJURY.