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

Lot Number PA0016

Device Problems Difficult or Delayed Positioning (1157); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

It was reported during surgery the endoscopic gastric release (egr138)/blade initially struggled to elevate, then once elevated would not recess.After more struggle the blade did retract and would no longer elevate.There was no injury or adverse consequences to the pt reported.Surgery was delayed for five minutes.

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 info.

• Brand Name: ENDOSCOPIC GASTROC RELEASE SYS (EGR138)
• Type of Device: ENDOSCOPIC GASTROC RELEASE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4016981
• MDR Text Key: 15324808
• Report Number: 3004608878-2014-00123
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2014

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 Lot Number: PA0016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR