INJECTION GOLD PROBE
Report
- Report Number
- 3005099803-2010-03509
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- July 31, 2010
- Report Date
- August 2, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MIAMI
- Product Code
- KNS
- PMA / PMN Number
- K961349
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
THE RETURNED INJECTION GOLD PROBE DEVICE WAS EVALUATED, AND THE REPORTED ISSUE OF THE DEVICE BEING UNABLE TO CAUTERIZE WAS CONFIRMED. THE DISTAL TIP SECTION WAS INSPECTED. THE CERAMIC TIP WAS VISUALLY INSPECTED, AND THE CERAMIC TIP FOUND TO BE MISSING SECTIONS OF THE GOLD STRIPE. IN ADDITION, THE CATHETER EXHIBITS EVIDENCE OF A KINK AT THE DISTAL TIP SECTION. NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED DURING THE ANALYSIS. A FUNCTIONAL ANALYSIS CANNOT BE PERFORMED, DUE TO THE MISSING GOLD AT THE TIP. THE STRUCTURAL INTEGRITY OF THE GOLD-SPIRAL ELECTRODE ON THE PROBE TIP HAS BEEN COMPROMISED WHICH LEAD TO THE DEVICE FAILURE. THE MISSING SECTIONS OF THE GOLD STRIPES ON THE CERAMIC TIP MAY HAVE RESULTED FROM THE REPEATED INTERACTION BETWEEN THE USE OF THE ELEVATOR AND THE GOLD TIP, WHICH MAY HAVE LED TO THE GOLD-SPIRAL BECOMING DAMAGED. THIS WOULD LEAD TO THE TIP NOT BEING ABLE TO APPLY ELECTROCAUTERY TO CAUTERIZE THE SITE. BASED ON THE DEVICE ANALYSIS, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.
(B)(4): THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING A HEMOSTASIS PROCEDURE FOR STOMACH ULCERS. ACCORDING TO THE COMPLAINANT, THEY WERE UNABLE TO USE THE INJECTION GOLD PROBE DEVICE. THE NEEDLE WAS ABLE TO EXTEND PROPERLY, AND WAS USED TO INJECT INTO THE DESIRED AREA. THE NEEDLE WAS RETRACTED, AND THEY WENT TO CAUTERIZE WITH HEAT. HOWEVER, THE DEVICE WAS NOT ABLE TO HEAT THE AREA, AND CAUTERIZE. THE DEVICE WAS TESTED WITH SALINE, AND WORKED. THE CABLES WERE ALSO CHECKED, AND FOUND TO WORK FINE WITH A DIFFERENT HEATER PROBE DEVICE; THE HEATER PROBE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED DURING A HEMOSTASIS PROCEDURE FOR STOMACH ULCERS. ACCORDING TO THE COMPLAINANT, THEY WERE UNABLE TO USE THE INJECTION GOLD PROBE DEVICE. THE NEEDLE WAS ABLE TO EXTEND PROPERLY, AND WAS USED TO INJECT INTO THE DESIRED AREA. THE NEEDLE WAS RETRACTED, AND THEY WENT TO CAUTERIZE WITH HEAT. HOWEVER, THE DEVICE WAS NOT ABLE TO HEAT THE AREA, AND CAUTERIZE. THE DEVICE WAS TESTED WITH SALINE, AND WORKED. THE CABLES WERE ALSO CHECKED, AND FOUND TO WORK FINE WITH A DIFFERENT HEATER PROBE DEVICE; THE HEATER PROBE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INJECTION GOLD PROBE | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC - MIAMI | M00560150 | 13339919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |