FDA Adverse Event Malfunction Summary report: N

RESOLUTION CLIP CLIPPING DEVICE

MDR report key: 6120054 · Received November 22, 2016

Report

Report Number: 3005099803-2016-03500
Event Type: Malfunction
Date Received: November 22, 2016
Date of Event: November 2, 2016
Report Date: November 3, 2016
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KOG
PMA / PMN Number: K040148
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SG
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED ISSUE OF CLIP DIFFICULT TO RELEASE FROM THE CATHETER. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP FAILED TO RELEASE FROM THE CATHETER. THE HANDLE WAS SQUEEZED FURTHER AND THE DEVICE WAS JIGGLED IN AN ATTEMPT TO DEPLOY THE CLIP; HOWEVER, THE SPRING FROM THE HANDLE CAME OFF. THE CLIP FINALLY RELEASED FROM THE CATHETER AFTER A FEW ATTEMPTS OF RIGOROUS PULLING AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
773226	RESOLUTION CLIP CLIPPING DEVICE	ENDOSCOPE AND/OR ACCESSORIES	KOG	BOSTON SCIENTIFIC - MARLBOROUGH	M00522611

Patients

Seq	Age	Sex	Outcome	Treatment
1