FDA Adverse Event Injury Summary report: N

ENDORINGS

MDR report key: 5510328 · Received March 18, 2016

Report

Report Number: 1528319-2016-00010
Event Type: Injury
Date Received: March 18, 2016
Date of Event: February 23, 2016
Report Date: March 18, 2016
Manufacturer: ENDOAID, LTD.
Product Code: FED
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: NJ, US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

THE ENDORINGS DEVICE IS INTENDED TO BE ATTACHED TO THE DISTAL END OF THE ENDOSCOPE TO FACILITATE ENDOSCOPIC THERAPY, TO BE USED FOR THE FOLLOWING: KEEPING THE SUITABLE DEPTH OF ENDOSCOPE FIELD OF VIEW. US ENDOSCOPY RECEIVED A REPORT REGARDING A PROCEDURE IN WHICH THE ENDORINGS DEVICE BECAME DETACHED FROM THE ENDOSCOPE. THE PHYSICIAN REPORTED THAT THE PATIENT HAD A VERY TIGHT SIGMOID. ON WITHDRAWAL FROM THE SIGMOID THE ENDORINGS DEVICE DETACHED FROM THE ENDOSCOPE. THE PHYSICIAN RETRIEVED THE ENDORINGS DEVICE USING A SNARE. THE RETRIEVAL RESULTED IN A FORTY-FIVE MINUTE DELAY TO THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE DEVICE DETACHMENT, NOR AS A RESULT OF THE DEVICE RETRIEVAL. THE MANUFACTURER OF THIS DEVICE HAS BEEN INFORMED OF THIS EVENT. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT MAY BE UPDATED. THE INSTRUCTIONS FOR USE (IFU) FOR THE DEVICE CONTAINS THE FOLLOWING PRECAUTIONS: THE ENDORINGS DEVICE IS NOT INTENDED FOR DEEP ILEAL INTUBATION. THE ENDORINGS DEVICE SHOULD NOT BE USED IN CASES WITH ACUTE, SEVERE COLITIS OR WHERE THERE IS A KNOWN COLONIC STRICTURE. WARNING: DO NOT APPLY A WATER SOLUBLE LUBRICANT TO THE COLONOSCOPE PRIOR TO FITTING THE ENDORINGS DEVICE ON THE COLONOSCOPE. DOING SO COULD CAUSE THE ENDORINGS DEVICE TO SLIP OFF THE COLONOSCOPE DURING USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
166294	ENDORINGS	ENDORINGS	FED	ENDOAID, LTD.	E100	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention