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

Catalog Number 310138

Device Problems Mechanical Problem (1384); Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2016

Event Type  Injury  

Event Description

It was reported the surgeon had a defective device.The blade would not engage when deployed.It was reported revision or medical intervention was required.It was also reported no patient injury is alleged.There was a 10 minute surgery delay.Additional information has been requested.

Manufacturer Narrative

Additional information received 14mar2016: the surgeon converted to an ¿open¿ gastroc rather than endoscopic.No other issues arose.

Manufacturer Narrative

Integra completed its internal investigation 9apr2016.The investigation included: method: 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 variance (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 one other customer complaint has been initiated based on the inability to deploy the egr cutting blade.The trend analysis failure rate is 0.094%.Conclusion: the egr device associated with this complaint was not returned for evaluation.As a result, a likely root cause cannot be identified since integra is unable to determine if the reported non-conformance was due to an out-of-box failure, mechanical failure during use or from user technique.

• 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: 5463164
• MDR Text Key: 39124535
• Report Number: 3004608878-2016-00037
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0023A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/12/2016; 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR