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

Catalog Number 310138

Device Problem Positioning Failure (1158)

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 blade for the device would not disengage/deploy.The surgeon was performing an endoscopic gastrocnemius resection using our egr kit.The item blade operation was checked prior to being handed to the surgeon.However, upon attempting to extend the blade in-situ, the mechanism malfunctioned.Upon examination, the silver shaft of the device had separated from the base and subsequently the trigger mechanism for the blade was not operational.The device was removed and a second egr kit was opened and utilized to complete the procedure.It was reported that although the device was in contact with the patient, no patient injury is alleged.No medical intervention was required.There was a surgery delay of 5 minutes.

Manufacturer Narrative

Integra has completed their internal investigation on 1dec2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint management database for similar complaints.Results: the egr 138 assembly (p/n 31-0101) associated with this complaint was part of egr 138 lot # pa0026, manufactured by an external supplier.A device history record review revealed there were no material non-conformances or variances associated with the inspection of the final product.The number of complaints for the inability to deploy the egr cutting blade is provided: (b)(4).Examination of the proximal end of the outer sleeve revealed that the outer sleeve was no longer attached to the outer sleeve hub.These two components are assembled using (b)(6) adhesive.Failure to secure or maintain these two parts together prevents the outer sleeve from moving in a full range of motion when the collar is rotated.Conclusion: there are three possible failure modes that would result in the outer sleeve separating from the outer sleeve hub: defects in the manufacturing of the outer sleeve or outer sleeve hub; improper assembly of the outer sleeve and outer sleeve hub; and, inadequate amount of applied (b)(6) adhesive or inadequate curing time and temperature.Potential failures that would be caused by defects in manufacturing are mitigated through the manufacturer's process quality control and is sufficiently controlled and verified with manufacturing records and certificates of conformance provided upon receiving.Each manufactured egr device is subjected to 100% manual inspection by the external supplier to verify that the collar rotates and the cutting blade deploys and retracts as intended.Further inspection was performed by the surgeon prior to use establishing a very low risk that a manufacturing related defect was the root cause of the complaint.The probable root cause is a failure due to an inadequate amount of applied (b)(6) adhesive or inadequate curing time and temperature.

• 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: 6061953
• MDR Text Key: 58823336
• Report Number: 3004608878-2016-00293
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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: 54 YR