MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-03-27 for OMNI-FLEX SUPPORT ARM 11050 manufactured by Integra Lifesciences Corporation Oh/usa.
[71097707]
Integra has completed their internal investigation on march 21, 2017. The investigation included: methods: evaluation of actual device; review of device history records; review of complaints history. Results: evaluation of returned device; evaluation verified customer information as valid. Clamp is broken. Dhr review; 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. No service history is on file for this device. Complaints history; two year look back for this device reveals no complaint history. No complaint history. No manufacturing or design related trend has been identified. Conclusion: the end users reason for return was verified. The root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[71097708]
It was reported that the device broke during a procedure. Additional information was received on march 8, 2017 advising that after 8 hours of hipec (hyperthermic intraperitoneal chemotherapy) surgery, the device broke and 3 operative room persons had kept the device up 25 minutes by hands. Some parts dropped from the broken part, but did not enter to patient? S cavity because there was a special cover? Bogotabag? Layer which is used in connection with this treatment. The loose parts were picked off by the bogotabag layer. No patient injury and no surgical delay reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125289-2017-00005 |
| MDR Report Key | 6437609 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-03-27 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2008-01-25 |
| Date Added to Maude | 2017-03-27 |
| 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 SONIA IRIZARRY |
| 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 SUPPORT ARM |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-03-27 |
| Returned To Mfg | 2017-02-20 |
| Catalog Number | 11050 |
| 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 | 2017-03-27 |