SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205
Report
- Report Number
- 3005099803-2010-03870
- Event Type
- Malfunction
- Date Received
- September 14, 2010
- Date of Event
- July 23, 2010
- Report Date
- August 24, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- MND
- PMA / PMN Number
- K020824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. 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.
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THERE WERE A TOTAL OF 5 BANDS, INTACT ON THE LIGATOR HEAD. FOUR BANDS WERE NOT DEPLOYED AND ONE BAND WAS FOUND DEPLOYED. THE TEETH ON THE LIGATOR HEAD WERE FOUND TO BE FREE OF DAMAGE. THE TRIP WIRE ON THE HANDLE ASSEMBLY COULD BE PROPERLY CINCHED INTO THE HANDLE SLOT. THE TRIP WIRE WAS ALSO WOUND AROUND THE DRUM, INDICATING THE HANDLE HAD BEEN TURNED TO DEPLOY THE BANDS. THE DEPLOYMENT THREAD WAS FOUND BROKEN AND REMAINED ATTACHED TO THE DISTAL END OF THE TRIP WIRE. A FUNCTIONAL CHECK WAS PERFORMED BY PULLING THE BROKEN DEPLOYMENT THREAD INTACT WITH THE LIGATOR HEAD. UPON THIS EVALUATION, THE REMAINDERS OF THE BANDS WERE FOUND TO DEPLOY WITHOUT ANY ISSUES. A FUNCTIONAL CHECK OF THE HANDLE FOUND THAT THE HANDLE KNOB WAS ABLE TO TURN TO TAKE UP SLACKS AND THERE WAS AN AUDIBLE CLICK HEARD AT EACH COMPLETE TURN. THE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER; THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT, AS EVIDENT OF THE BROKEN THREAD ASSEMBLY. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN UPPER GASTROSCOPY BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND HOWEVER, IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THEY ATTEMPTED TURNING THE HANDLE SEVERAL TIMES HOWEVER, THE BANDS WOULD NOT DEPLOY. THEY REMOVED THE SCOPE AND DEVICE FROM THE PATIENT AND WITH ANOTHER ATTEMPT, WERE ABLE TO DEPLOY ONE BAND OUTSIDE OF THE PATIENT HOWEVER, A SECOND ATTEMPT FAILED TO DEPLOY A BAND. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN UPPER GASTROSCOPY BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND HOWEVER, IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THEY ATTEMPTED TURNING THE HANDLE SEVERAL TIMES HOWEVER, THE BANDS WOULD NOT DEPLOY. THEY REMOVED THE SCOPE AND DEVICE FROM THE PATIENT AND WITH ANOTHER ATTEMPT, WERE ABLE TO DEPLOY ONE BAND OUTSIDE OF THE PATIENT HOWEVER, A SECOND ATTEMPT FAILED TO DEPLOY A BAND. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC - SPENCER | M00542253 | 13446118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |