MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA OMNI-FLEX STERILE FIELD POST; SURGICAL RETRACTOR

Catalog Number 10244

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

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 information.

Event Description

Customer initially reports bottom part of omni post (clamp) doesn¿t tighten down to bed rail.Exhibits movement.On (b)(6) 2017 customer can not provide further information, answers from or not forthcoming.

Manufacturer Narrative

Investigation completed 01/02/2018.Device history record reviewed for product id: 10244, lot code: 167 was manufactured on 25aug2017 with no associated mrr¿s, variances or rework.The handle is bent on the post clamp subassembly allowing the clamp to rotate while in the locked position.General maintenance needed.Previous repairs documented on returned unit.Failure analysis to identify root cause confirmed complaint event.Most likely reason is wear and tear.

• Brand Name: OMNI-FLEX STERILE FIELD POST
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7115207
• MDR Text Key: 95768836
• Report Number: 2125289-2017-00017
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10244
• Device Lot Number: 167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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