MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ¿EGR SYSTEM (STERILE)¿; ENDOSCOPIC GASTROC RELEASE

Catalog Number ¿310040¿

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

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the egr system blade is not retracting.The device was not in contact with the patient, no patient injury reported however, revision/medical intervention was required.Additional information was requested, no further information will be provided.

Manufacturer Narrative

Integra has completed their internal investigation on november 7, 2016.The investigation included: methods: review of device history records review of complaints history results: dhr review; egr 157 assembly lot # pa0022, consisting of (b)(4) units, was assembled on april 22 ¿ 28, 2015 and inspected on april 24 ¿ 29, 2015.Final audit activities at pti involved a 100% inspection of each egr assembly.Packaged and sterilized egr 157 lot # pa0022a1, consisting of (b)(4) pieces, was received at (b)(4) on june 19, 2015, inspected (n = 8) and released into finished goods inventory on june 22, 2016.There were no material non-conformances or variance associated with inspection of the final product.Complaints history; a query in our complaint management system determined that fourteen (14) other customer complaints have been initiated based on the inability for the egr cutting blade to retract.The query was based on the individual assembly part numbers 31-0001, 31-0101, the system catalog numbers 310040 and 310138 and the terms ¿endoscopic¿ and ¿egr¿ and covered the time frame of january 1, 2014 ¿ october 25, 2016.Conclusion: the egr 157 device associated with this complaint was not returned for evaluation.As a result, a likely root cause can 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.Integra lifesciences continues to monitor the field for all issues associated with the egr devices, and further action will be taken if any new risks or adverse trends are identified.

• Brand Name: ¿EGR SYSTEM (STERILE)¿
• 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: 6069680
• MDR Text Key: 59220937
• Report Number: 3004608878-2016-00296
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ¿310040¿
• Device Lot Number: PA0022A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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