MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-01-04 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[63913948]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[63913949]
Customer initially reported device to be repaired. Additional information received on december 20th 2016 : the problem is the teflon ring does not have enough tension and during the operation the system collapsed. The operation was extended a couple of minutes, but no damage to the patient.
Patient Sequence No: 1, Text Type: D, B5
[69126392]
On 2/2/2017 integra investigation completed. Method failure analysis, device history evaluation. Results: failure analysis - the sterile field post clamp is out of our specification. The bolt is worn off. Device history evaluation - device history record reviewed for this product id work order shows 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. Conclusion: the assembly had to be repaired before this testing could be initiated. When the worn bolt was replaced, the unit was able to be mounted to the test rail and then tested to specification. This device has been in service for more than 6 years without service. The likely root cause for the failure mode is wear and tear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00017 |
| MDR Report Key | 6223756 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-13 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2010-08-06 |
| Date Added to Maude | 2017-01-04 |
| 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 | 2017-01-04 |
| Returned To Mfg | 2016-12-12 |
| Catalog Number | 10244 |
| Lot Number | M38407 |
| 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 | 2017-01-04 |