MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS ENDOSTRATUS CO2 INSUFFLATOR; ENDOSCOPIC INSUFFLATOR

Model Number EGA-501

Device Problem Device Handling Problem (3265)

Patient Problem Tissue Damage (2104)

Event Date 06/10/2014

Event Type  No Answer Provided  

Event Description

The case states that the pressure of a co2 insufflator caused the patient's stomach to over extend and rip during a procedure.

Manufacturer Narrative

This case was reported by a medivators sales rep who was contacted by the facility with regards to a medivators endostratus co2 insufflator being in their shop.The endo department claimed that this co2 insufflator pump was the cause for a patient's stomach to over expand and rip.The facilities internal repair/service personnel reported that there was no problems found with the co2 insufflator pump.Also noted, the patient involved was elderly and likely susceptible to procedural complications.The co2 pump showed no indication of malfunction or being out of specification.It is unlikely the pump is the cause for the patient's stomach to rip for reasons as follows: 1- the attending physician is ultimately responsible to modulate and control delivery of co2 to the patient.2- the unit has a internal safety relief valve when pressure reaches greater than 12 psi.3- there is an immediate pressure drop upon the exit of co2 from the distal tip and what the original output pressure that comes from the insufflator machine itself.To clarify, there is not a direct correlation between the co2 pressure contacting the patients stomach/tissue and what the output pressure is reading on the machine.There is limited information as to the current condition of the patient.This complaint will be monitored and filed within medivators complaint system.

• Brand Name: MEDIVATORS ENDOSTRATUS CO2 INSUFFLATOR
• Type of Device: ENDOSCOPIC INSUFFLATOR
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 3916230
• MDR Text Key: 4664500
• Report Number: 1651395-2014-00003
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EGA-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1