MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-31 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[53575285]
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.
Patient Sequence No: 1, Text Type: N, H10
[53575286]
Customer initially reports the unit slips and will not hold tension. On (b)(6) 2016 customer reports no harm done, no damage, no further information available.
Patient Sequence No: 1, Text Type: D, B5
[59252590]
On 10/04/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - complaint confirmed. Unit received has a bent handle on the post clamp subassembly allowing the clamp to rotate on the post when in the locked position. This unit is also mis etched as a (b)(4) when it is actually a 11502r sterile field post. No previous repair codes. Device history evaluation - device history record reviewed for these product ids under lot codes 154 respectively show no abnormalities related to reported incident found. These device passed all required inspection points with no associated mrr? S, variances or rework. No previous service history is on file. Conclusion: the end users reason for return was verified the most probable cause could be use error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00006 |
| MDR Report Key | 5917330 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-12 |
| Date Mfgr Received | 2016-10-04 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2016-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI-FLEX STERILE FIELD POST |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-15 |
| Catalog Number | 10244 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-31 |