MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-03 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[69099890]
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
[69099891]
Customer initially reports post will not hold retractor securely. (b)(6) 2017 reports esophagectomy transhiatal was being performed. Retractor was attached to table after incision was made, discovered that the retractor would not hold, within the first hour. It was replaced. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
[73824526]
On 3/27/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - evaluation verified customer information as valid. Device failed dimensional and functional checks. Device shows normal wear and tear on outside, but when disassembles excessive wear is obvious. Cam is visually bent and there are wear marks on. 500 dia indicating over use. Cam body has visual wear marks from excess handle throw. Peek cam bolt bushing. 390 internal diameter is visually worn on throw side. 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. Conclusion: in summary the end users reason for return was verified the most probable cause could be use error. Please note that a capa has been issued to further investigate this reported failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2017-00002 |
| MDR Report Key | 6378005 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2015-05-04 |
| Date Added to Maude | 2017-03-03 |
| 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 | 2017-03-03 |
| Returned To Mfg | 2017-02-17 |
| Catalog Number | 10244 |
| Lot Number | 154 |
| 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 | 2017-03-03 |