MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-21 for OMNI-FLEX SUPPORT ARM 11050 manufactured by Integra Lifesciences Corporation Oh/usa.
[96061589]
Investigation completed 12/13/2017. The device history record for product id 11050 lot code 171 manufactured on 3/28/2017 showed no abnormalities related to reported incident found nor were there any variances, mrr? S or reworks associated with either lot &/or work order number. Evaluation verified customer information as valid. Clamp does not build enough pressure up. Root cause is most likely accelerated wear and tear of parts internal to clamp.
Patient Sequence No: 1, Text Type: N, H10
[96061590]
Customer reports the support arm moves with a slight force while in locked position. No harm done. #2 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00151 |
| MDR Report Key | 7137387 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-21 |
| Date of Report | 2017-11-28 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-21 |
| 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 SUPPORT ARM |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-12-21 |
| Returned To Mfg | 2017-12-04 |
| Catalog Number | 11050 |
| Lot Number | 171 |
| 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 | 2017-12-21 |