MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for GRIESHABER REVOLUTION DSP FORCEPS 705.44P manufactured by Alcon Grieshaber Ag.
[182341723]
No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182341724]
A health professional reported that an ophthalmic forceps device became clamped shut and would not open during surgery. Patient impact information is unknown. Additional information has been requested. Additional information received clarified that the unsatisfactory forceps would not reopen during a vitrectomy procedure. An alternate forceps was obtained in order to successfully complete the procedure. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2020-00013 |
| MDR Report Key | 9664350 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-01-11 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIESHABER REVOLUTION DSP FORCEPS |
| Generic Name | FORCEPS, OPHTHALMIC |
| Product Code | HNR |
| Date Received | 2020-02-04 |
| Model Number | NA |
| Catalog Number | 705.44P |
| Lot Number | 278496M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER AG |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN 8203 SZ 8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |