MICROVASIVE GOLD PROBE
Report
- Report Number
- 3005099803-2011-00586
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 3, 2011
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA
- Product Code
- KNS
- PMA / PMN Number
- K885005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ZA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FINGER RING HAD PARTIALLY SEPARATED FROM THE HANDLE. ADDITIONALLY, THE HANDLE CANNULA HAD DETACHED FROM THE FINGER RING, WHICH CAUSED THE WIRE TO PROTRUDE FROM THE SHEATH. EVIDENCE OF WEAR WAS FOUND INSIDE THE HANDLE BODY, SUGGESTING AN INTERACTION BETWEEN THE ROD AND THE PLASTIC HOUSING OF THE HANDLE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT "THE WIRE SNAPPED AT THE HANDLE"; THE COMPLAINT WAS CONFIRMED. ALTHOUGH THE WIRE WAS NOT FOUND TO BE BROKEN, IT IS LIKELY THAT THE SEPARATION OF THE FINGER RING CAUSED DETACHMENT OF THE HANDLE CANNULA, THE LATTER OF WHICH THE CUSTOMER HAS REFERRED TO AS "THE WIRE." A DEFINITIVE ROOT CAUSE FOR THE DEFECTS IDENTIFIED COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION JUMBO OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE WIRE WITHIN THE SHEATH PROTRUDED AT THE PROXIMAL PART OF THE SHEATH (JUST BEFORE THE HANDLE) WHEN THE PHYSICIAN ATTEMPTED TO EXTEND THE SNARE. IT IS UNKNOWN IF THE SHEATH DETACHED OR TORE AND WHETHER THE WIRE WAS BENT OR BROKEN. FURTHERMORE, IT IS UNKNOWN IF THE WIRE DETACHED. THE DEVICE HAD BEEN COMPLETELY UNCOILED PRIOR TO USE AND NO BENDS OR KINKS WERE NOTED IN THE PLASTIC SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION JUMBO OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN CLARIFICATION OF THE EVENT DESCRIPTION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ANY RELEVANT INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION JUMBO OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE WIRE WITHIN THE SHEATH PROTRUDED AT THE PROXIMAL PART OF THE SHEATH (JUST BEFORE THE HANDLE) WHEN THE PHYSICIAN ATTEMPTED TO EXTEND THE SNARE. IT IS UNKNOWN IF THE SHEATH DETACHED OR TORE AND WHETHER THE WIRE WAS BENT OR BROKEN. FURTHERMORE, IT IS UNKNOWN IF THE WIRE DETACHED. THE DEVICE HAD BEEN COMPLETELY UNCOILED PRIOR TO USE AND NO BENDS OR KINKS WERE NOTED IN THE PLASTIC SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION JUMBO OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN CLARIFICATION OF THE EVENT DESCRIPTION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ANY RELEVANT INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROVASIVE GOLD PROBE | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC - COSTA RICA | M00562650 | 13522749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |