MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA OMNI-FLEX SUPPORT ARM; SURGICAL RETRACTOR

Catalog Number 11050

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on march 21, 2017.The investigation included: methods: evaluation of actual device; review of device history records; review of complaints history.Results: evaluation of returned device; evaluation verified customer information as valid.Clamp is broken.Dhr review; no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.Complaints history; two year look back for this device reveals no complaint history.No complaint history.No manufacturing or design related trend has been identified.Conclusion: the end users reason for return was verified.The root cause could not be determined.

Event Description

It was reported that the device broke during a procedure.Additional information was received on march 8, 2017 advising that after 8 hours of hipec (hyperthermic intraperitoneal chemotherapy) surgery, the device broke and 3 operative room persons had kept the device up 25 minutes by hands.Some parts dropped from the broken part, but did not enter to patient¿s cavity because there was a special cover ¿bogotabag¿ layer which is used in connection with this treatment.The loose parts were picked off by the bogotabag layer.No patient injury and no surgical delay reported.

• Brand Name: OMNI-FLEX SUPPORT ARM
• Type of Device: SURGICAL RETRACTOR
• 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: 6437609
• MDR Text Key: 71097707
• Report Number: 2125289-2017-00005
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2008
• 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