DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Report

• Report Number: 3005580113-2020-00344
• Event Type: Injury
• Date Received: April 2, 2020
• Report Date: April 2, 2020
• Manufacturer: COOK IRELAND LTD
• Product Code: KNS
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Distributor report
• Reporter Location: MN, US
• Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC.

Description of Event or Problem · 1

THE RATE OF SYMPTOMATIC STRICTURES AFTER EMR WAS LOW AT 1.0% PER PATIENT (7 CASES). NONE OF THE CASES HAD USED INTERVENING PDT AND ALL STRICTURES OCCURRED WITH EMR ONLY. ALL STRICTURE CASES WERE SUCCESSFULLY TREATED WITH ENDOSCOPIC DILATION (12 BALLOON DILATIONS AND 2 SAVARY DILATIONS IN TOTAL). ON AVERAGE, TWO DILATIONS WERE NEEDED TO OBTAIN LONG-LASTING RELIEF FROM STRICTURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379883	DUETTE MULTI-BAND MUCOSECTOMY DEVICE		KNS	COOK IRELAND LTD		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention

Terms

Patient problem · 1

• Occlusion

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission