MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for RUGGLES FUKUSHIMA RETRACTION SYSTEM WITH STERILI R9100 manufactured by Integra York, Pa Inc..
[72522506]
On 3/24/2017 integra investigation completed: method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. No device returned for further evaluation. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable. Engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Instrument was not returned.
Patient Sequence No: 1, Text Type: N, H10
[72522507]
Customer reports the first time this new fukushima retractor was used doctor was disappointed that the retractor arms did not stay in position? Did not hold as much tension as he expected. No specific case/patient data available. No injury or delay to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00043 |
| MDR Report Key | 6475450 |
| Date Received | 2017-04-10 |
| Date of Report | 2017-03-15 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2017-04-10 |
| 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 YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RUGGLES FUKUSHIMA RETRACTION SYSTEM WITH STERILI |
| Generic Name | N/A |
| Product Code | HBG |
| Date Received | 2017-04-10 |
| Catalog Number | R9100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-10 |