MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MALLONEY FR28F, P/N9213; ESOPHAGEL BOUGIE

Catalog Number MEDICAL UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2011

Event Type  malfunction  

Event Description

Alleged event: issue occurred in (b)(6) where the patient/plaintiff was undergoing laparoscopic bariatric surgery in which there was a need to pass an orogastric tube through the esophagus into the stomach, but difficulty was encountered in attempting to pass the tube.A bougie was passed into the stomach successfully, but even this did not make the tube pass through the esophagus.So, the surgeon attempted to laparoscopically attach a suture to the end of the bougie so that the suture could be pulled out through the patient's esophagus with removal of the bougie, then attached to the orogastric tube to pull the orogastric tube back into the stomach.The surgeon did not realize that the bougie contained mercury, and the procedure resulted in some mercury being released into the patient's abdomen.The attorney for the surgeon indicated that the patient did not suffer any significant ill effects.There was a (b)(6) 2011) submitted that reported the same event: pt scheduled for laparoscopic roux-en-y procedure.Difficult placement of ng tube requiring placement of bougie dilator to assist in naso-gastric insertion which was the final phase of the operative procedure to assure no evidence of leak.Bougie was a rusch hurst style manufactured prior to 2003.Bougie was modified to assist in the insertion of the nasogastric tube.A suture was placed through one end of the dilator with a tail of suture material attached.It was discovered that the suture had apparently punctured the liner lumen of the dilator, allowing mercy to escape outside of the dilator.Event was reported by a risk manager.The (b)(4) report stated a rusch hurst style but the brand name was listed as a rusch malloney fr28f.No contact information was provided.

Manufacturer Narrative

Qn # (b)(4).A complaint history review was conducted on the catalog number in question from 01/05/2010 to 01/06/2015.Since the catalog number is unknown it cannot be related to any complaint for same catalog number and same issue.The device sample is not expected for investigation since the event was received from medwatch.The manufacturer will continue to monitor and trend related events.

• Brand Name: RUSCH MALLONEY FR28F, P/N9213
• Type of Device: ESOPHAGEL BOUGIE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4432978
• MDR Text Key: 5420745
• Report Number: 3004365956-2015-00016
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MEDICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1