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

Catalog Number 310138

Device Problems Retraction Problem (1536); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the blade for the endoscopic release kit would not disengage.During a procedure this morning, the surgeons were unable to make the blade on the endoscopic gastric release kit retract.As a result, they converted the procedure to a partial open approach.It was reported the patient was not injured.

Manufacturer Narrative

Integra has completed their internal investigation on 24feb2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: (b)(4).Conclusion: 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 left side of the polycarbonate end cap.Application of force resulted in a partial shearing of the inner surface of the polycarbonate end cap, resulting in an attached fragment that blocked the passage of the blade.

Event Description

This event was reported for clinical risk of patient injury.No actual patient injury reported.

• 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: 5386678
• MDR Text Key: 36707158
• Report Number: 3004608878-2016-00014
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

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: PA0023A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR