FDA Adverse Event Malfunction Summary report: N

SPEEDBAND SUPERVIEW SUPER 7¿

MDR report key: 2830255 · Received November 13, 2012

Report

Report Number: 3005099803-2012-05291
Event Type: Malfunction
Date Received: November 13, 2012
Date of Event: October 22, 2012
Report Date: October 24, 2012
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: MND
PMA / PMN Number: K020824
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BANDS WERE NOT ABLE TO BE DEPLOYED FROM THE SPEEDBAND DEVICE. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. 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 FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPEEDBAND SUPERVIEW SUPER 7¿	LIGATOR, ESOPHAGEAL	MND	BOSTON SCIENTIFIC - SPENCER	M00542253

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR