FDA Adverse Event Malfunction Summary report: N

ENDOLUMINA II TRANSILLUMINATED BOUGIE

MDR report key: 148559 · Received February 3, 1998

Report

Report Number: 2028368-1998-00001
Event Type: Malfunction
Date Received: February 3, 1998
Report Date: January 6, 1998
Manufacturer: BIOENTERICS CORPORATION
Product Code: KCD
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

PHYSICIAN REPORTED THAT ON THREE SEPARATE OCCASIONS AND DURING PROCEDURES, THE DETACHABLE TIPS CAME OFF OF THE ENDOLUMINA(R) II TRANSILLUMINATED BOUGIE'S (EIB II) TRANSILLUMINATOR CABLE, 56 FRENCH SIZE. THE SURGEON REPORTED THAT AFTER INSERTION DOWN THE PT'S ESOPHAGUS AND WHILE ATTEMPTING TO REMOVE THE DEVICES, THE TIPS CAME OFF THE CABLE CONNECTOR AND REMAINED IN THE PT. THE SURGEON REPORTED THIS OCCURRED IN THREE SEPARATE SURGICAL PROCEDURES: (1)PARAESOPHAGEAL HERNIA REPAIR AND ENDOSCOPY WAS REQUIRED TO REMOVE THE TIP, (2)NISSEN FUNDOPLICATION AND THE TIP WAS REMOVED FROM THE ORAL PHARYNX WITH A GRASPING INSTRUMENT, AND (3)NISSEN FUNDOPLICATION AND ENDOSCOPY WAS REQUIRED TO REMOVE THE TIP FROM THE PT'S STOMACH. THE PHYSICIAN REPORTED THAT THEY ARE NOT REUSING THE TIPS AND ARE DISPOSING OF THEM AFTER SURGERY. WITH THE FIRST AND SECOND PROCEDURES, THE TIPS WERE DISCARDED; HOWEVER, THE TIP FROM THE THIRD PROCEDURE AND THE TRANSILLUMINATOR CABLE WAS RETURNED TO BIOENTERICS CORPORATION FOR EVALUATION. THE PHYSICIAN REPORTED THAT HE HAS PERFORMED 28 NISSEN PROCEDURES. HE INDICATED THAT THE FIRST TWO INCIDENTS MAY HAVE BEEN TECHNIQUE RELATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOLUMINA II TRANSILLUMINATED BOUGIE	TRANSILLUMINATING BOUGIE	KCD	BIOENTERICS CORPORATION	56 FRENCH	B97ET051

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Hospitalization\| R