SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204
Report
- Report Number
- 3005099803-2010-04493
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- MND
- PMA / PMN Number
- K020824
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 A TOTAL OF THREE BANDS (TWO BLUE AND ONE WHITE) WERE FOUND INTACT ON THE LIGATOR HEAD WHICH WERE NOT DEPLOYED AND WERE TWISTED ON THE LIGATOR HEAD ASSEMBLY. THE TEETH ON THE LIGATOR HEAD WERE FOUND TO BE DAMAGED LIKELY DUE TO THE USAGE OF THE DEVICE. THE TRIP WIRE ON THE HANDLE ASSEMBLY WAS FOUND TO BE CINCHED INTO THE HANDLE SLOT BUT WAS BROKEN AT THE PROXIMAL END. THE TRIP WIRE WAS ALSO WOUND AROUND THE DRUM, INDICATING THE HANDLE HAD BEEN TURNED TO DEPLOY THE BANDS. THE DEPLOYMENT THREAD WAS FOUND SEPARATED FROM THE LIGATOR HEAD BUT WAS NOT BROKEN AND REMAINED ATTACHED TO THE DISTAL END OF THE TRIP WIRE. 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 MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT. IT IS LIKELY THAT ANATOMICAL/PROCEDURAL/OPERATIONAL FACTORS IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS AND CAUSED THE TEETH ON THE LIGATOR HEAD TO INADVERTENTLY DAMAGE DURING USE. THIS CAN IN TURN CAUSE THE BANDS TO STACK UP ON THE LIGATOR HEAD AND HINDER THE DEPLOYMENT ACTIVITY OF THE DEVICE. 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 ESOPHAGEAL BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE OF THE PATIENT, THE PHYSICIAN WAS TESTING THE DEVICE. THE FIRST THREE BANDS DEPLOYED AS DESIGNED. WHEN AN ATTEMPT WAS MADE TO DEPLOY THE FOURTH BAND, THEY NOTICED THAT THE SUTURE WAS NOT ATTACHED TO THE TEETH OF THE LIGATOR HEAD PROPERLY. THEREFORE, THE BAND WOULD NOT DEPLOY. THE CASE WAS COMPLETED WITH ANOTHER 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 ESOPHAGEAL BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE OF THE PATIENT, THE PHYSICIAN WAS TESTING THE DEVICE. THE FIRST THREE BANDS DEPLOYED AS DESIGNED. WHEN AN ATTEMPT WAS MADE TO DEPLOY THE FOURTH BAND, THEY NOTICED THAT THE SUTURE WAS NOT ATTACHED TO THE TEETH OF THE LIGATOR HEAD PROPERLY. THEREFORE, THE BAND WOULD NOT DEPLOY. THE CASE WAS COMPLETED WITH ANOTHER 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 4204 | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC - SPENCER | M00542251 | 13325442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |