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

Catalog Number 310138

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the blade of the endoscopic gastroc release system (egr) would not retract.Although the device was in contact with the patient, no injury was reported, and no revision or medical intervention was required.The surgery was delayed 15 minutes due to the product problem.No further information provided.

Manufacturer Narrative

Integra has completed their internal investigation on august 26, 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: evaluation of returned device; examination of the cutting blade under 10x magnification revealed that the blade was unable to pass through the polycarbonate end cap.The cutting blade was lodged against the right side of the polycarbonate end cap blocking the passage of the blade.Examination of the rotating collar determined that both plastic cannula hub ferrules had been sheared off and that the collar no longer functioned as designed.Dhr review; (b)(4) units was received at (b)(4) on february 1, 2016, inspected and released into finished goods inventory on february 25, 2016.There were no material non-conformances or variances associated with the inspection of the final product.Complaints history; ten (10) other customer complaints have been initiated based on the inability for the egr cutting blade to retract in the time frame of january 1, 2014 ¿ august 1, 2016 conclusion: (root/cause) based on the inspection of the returned device, the likely root cause for this complaint was that the cutting blade was not completely centered when the surgeon attempted to retract the blade.As a result, the reverse edge of the blade came into contact with the right side of the polycarbonate end cap.Application of force resulted in shearing off of the cannula hub ferrules, which prevented the rotating collar from functioning as designed.

• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5773097
• MDR Text Key: 49641992
• Report Number: 3004608878-2016-00179
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1