MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-05 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[92064760]
On 10/23/2017 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - complaint confirmed. Unit received does not properly attach to the rail. All other functional tests passed. General maintenance needed. Device history evaluation - a total of (b)(4) were produced of this lot in 2016. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework, see below. No service history is on file for this device. Conclusion - most likely reason for complaint event is wear and tear.
Patient Sequence No: 1, Text Type: N, H10
[92064761]
Customer initially reports the bottom part of omni post (clamp) doesn't tighten down to bed rail. Exhibits movement. On (b)(6) 2017 customer reports "a whipple procedure was being performed. Attached the post to the bed and when attaching the bar that attaches to the omni post and locking into place the whole arm would move. No harm to patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125289-2017-00016 |
| MDR Report Key | 7002336 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-05 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-11-05 |
| 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 | 2017-11-05 |
| Returned To Mfg | 2017-10-20 |
| Catalog Number | 10244 |
| Lot Number | 169 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-11-05 |