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

Catalog Number 310138

Device Problems Retraction Problem (1536); Failure to Shut Off (2939)

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 on the device would not disengage.A back up of the same product was opened and worked fine.It was reported there was a surgery delay of 20-30 minutes.It was reported that it was unknown if the device was in contact with the patient; however, no patient injury is alleged.No medical intervention was required.The patient was prepped for surgery.

Manufacturer Narrative

Integra completed its internal investigation 31oct2016.The investigation included: method: - 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 # pa0025.A device history record review revealed that egr 138 assembly lot # pa0025 was assembled on september 25 ¿ october 6, 2015 and inspected on september 25 ¿ october 6, 2015.The lot was 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.A query in the electronic database determined that fourteen (14) other customer complaints have been initiated based on the inability for the egr cutting blade to retract.The trend analysis complaint rate was performed by determining the number of reported non-conformances for the egr 157 and egr 138 systems.Egr complaint trend (b)(4).Notes: one returned device from lot pa0016 worked as designed.Conclusion: the egr 138 assembly associated with this customer complaint was not returned for evaluation.This prevented integra from performing a complaint analysis and identifying a likely root cause.

• 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: 6061952
• MDR Text Key: 59016034
• Report Number: 3004608878-2016-00292
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• 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: 43 YR