SPEEDBAND SUPERVIEW SUPER 7?
Report
- Report Number
- 3005099803-2014-04071
- Event Type
- Malfunction
- Date Received
- December 31, 2014
- Date of Event
- December 8, 2014
- Report Date
- December 8, 2014
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FHN
- PMA / PMN Number
- K020824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTED ISSUE OF BANDS FAILED TO DEPLOY. 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.
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THE EXTENSION TUBE WAS WITHOUT ISSUE. ALL SEVEN BANDS WERE PRESENT ON THE LIGATOR HEAD; HOWEVER, THE LIGATION BANDS WERE MOVED OUT OF POSITION. ONE BLUE LIGATION BAND WAS BROKEN AND CAUGHT UNDER THREE OTHER BANDS. THE LIGATOR HEAD TEETH WERE VERY BADLY DAMAGED WITH SEVERAL TEETH NEARLY BROKEN. THE SUTURE WAS INTACT AND ATTACHED TO THE TRIP WIRE LOOP. THE TRIP WIRE AND SUTURE WERE FULLY WRAPPED AROUND THE HANDLE SPOOL. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT; HOWEVER, THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. THERE WAS NO EVIDENCE PRESENT THAT THE TRIP WIRE AND THE HANDLE ASSEMBLY SLOT HAD BEEN SECURED DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180º AND AN AUDIBLE CLICK WAS HEARD, NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE INVESTIGATOR NOTED THAT THE DEVICE MOST LIKELY FAILED TO DEPLOY THE BANDS EVEN THOUGH THIS COULD NOT BE FUNCTIONALLY VERIFIED. IT DOES NOT APPEAR THAT THE TRIP WIRE WAS CINCHED IN THE HANDLE SLOT AS INSTRUCTED IN THE DFU, WHICH IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTROESOPHAGEAL JUNCTION (GE JUNCTION) DURING A BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE BAND; HOWEVER, AFTER SEVERAL ATTEMPTS THE BANDS DID NOT RELEASE TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE SCOPE AND IT WAS NOTICED THAT ALL THE BANDS WERE INTERTWINED. ANOTHER SPEEDBAND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTROESOPHAGEAL JUNCTION (GE JUNCTION) DURING A BANDING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE BAND; HOWEVER, AFTER SEVERAL ATTEMPTS THE BANDS DID NOT RELEASE TO DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE SCOPE AND IT WAS NOTICED THAT ALL THE BANDS WERE INTERTWINED. ANOTHER SPEEDBAND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861486 | SPEEDBAND SUPERVIEW SUPER 7? | LIGATOR, HEMORRHOIDAL | FHN | BOSTON SCIENTIFIC - SPENCER | M00542250 | 16731031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |