MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)

Catalog Number 310138

Device Problems Retraction Problem (1536); Mechanics Altered (2984)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the device blade would not lower during a procedure.It was reported the surgeon tested the blade prior to use and used the device ¿per technique.¿ once the surgeon made his first pass cutting the aponeurosis he went to turn the knob to lower/remove the cutting blade and it would not lower down.He tried several times.He then flushed saline through the saline port to help remove any lodged tissue that may have been blocking the device from working properly.That did not help.The surgeon carefully removed the device with a deployed blade.He then went back in with the scope only to confirm all bands have been cut.He noticed a few that still needed to be cut.A new device was opened so he could complete the case without injury to the patient.It was reported that although the device was in contact with the patient, no injury is alleged.

Manufacturer Narrative

Integra completed its internal investigation 11oct2016.The investigation included: method: - evaluation of actual device.- review of device history records.- review of complaint management database for similar complaints.Results: a review of the device history record revealed that egr 138 assembly lot # pa0023, consisting of (b)(4) units, was assembled on march 23, 2015 and april 1, 2015 and inspected on april 1-2, 2015.Gamma sterilization occurred on june 10, 2015.Packaged and sterilized egr 138 lot # pa0023 was received at (b)(4) june 15, 2015, inspected and released into inventory on june 16, 2015.There were no variances associated with this shipment.(b)(4) issued (b)(4) to allow portions of the four components that make up the egr system to be given a unique lot number based on individual work orders.As a result, the outer package product label for the first work order identified the system as lot # pa0023a1.A query in the electronic data base determined that eleven (11) other customer complaints have been initiated based on the inability for the egr cutting blade to retract.(b)(4).Conclusion: the likely root cause, based on the examination of the returned instrument is that the cutting blade would not retract due to the presence of an excessive amount of biological tissue in the distal end of the assembly.The tissue (as observed) was on the left side of the cutting blade and inner sleeve preventing the actuation mechanism from performing as designed.Application of excessive force resulted in the cross pin breaking free of the outer sleeve.

• Brand Name: ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)
• Type of Device: ENDOSCOPIC GASTROC RELEASE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5946070
• MDR Text Key: 54889962
• Report Number: 3004608878-2016-00246
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR