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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that initially the blade would deploy and disengage.After cutting the aponeurosis the blade would no longer disengage.Surgeon was unable to use the device to check for completion and had to finish the procedure with a blade.Surgeon reported that he has dealt with this issue multiple times.He likes the system and continues to use it, but is always fearful that the blade will have problems at some point during the procedure.

Manufacturer Narrative

Integra has completed their internal investigation on april 03, 2017.The investigation included: methods: evaluation of actual device; review of device history records; review of complaints history.Results: evaluation of returned device; the failure analysis conducted for this customer complaint confirmed a malfunction of an egr 138 assembly.Examination of the cutting blade under 10x magnification revealed that the blade was no longer centered relative to the distal end of the device and was unable to pass through the polycarbonate end cap.Attempts to retract the blade using the collar were unsuccessful since the cutting blade came into direct contact with the right side of the polycarbonate end cap.Analysis of previously returned egr devices identified that misalignment of the cutting blade can prevent the blade from passing through the polycarbonate end cap.When this occurs, application of excessive force can lead to device failure; which can include (1) fracture of the polycarbonate end cap; (2) shearing of the cannula hub ferrules; (3) a broken cross pin; and (4) internal damage to the cam mechanism.Dhr review; there were no material non-conformances or variances associated with the inspection of the final product.Complaints history; a query in trackwise determined that five (5) other customer complaints have been initiated based on the inability for the egr cutting blade to retract.The query was based on a combination of the individual assembly part numbers 31-0001, 31-0101, the (b)(4) system numbers 310040 and 310138 and the terms ¿endoscopic¿ and ¿egr¿ and covered the time frame of january 1, 2015 ¿ march 27, 2017: units sold 1,392, complaint rate 0.431%.Conclusion: based on the inspection of the returned device, a likely root cause for this complaint could not be determined.Although the cutting blade was no longer centered relative to the opening in the poly carbonate end cap, it wasn¿t possible to determine if this was due to mechanical failure of the device or if excessive force was exerted during an attempt to retract the blade.

• 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: 6429943
• MDR Text Key: 70989935
• Report Number: 3004608878-2017-00076
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0026A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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