MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for GRIESHABER REVOLUTION DSP SCISSORS 706.52 manufactured by Alcon Grieshaber Ag.
[120136850]
A sample is available that has not yet been received at 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. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[120136851]
A nurse reported that an ophthalmic scissors could not cut, open or close during a vitrectomy surgery. The incision site had to be enlarged in order to remove the scissors device from the patient's eye with no report of further harm experienced. Additional information received clarified that the procedure time was prolonged while removing the scissors from the eye, but that resulted in no complications for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2018-00027 |
| MDR Report Key | 7866088 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2018-09-11 |
| 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 | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | 0 |
| Brand Name | GRIESHABER REVOLUTION DSP SCISSORS |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | HNF |
| Date Received | 2018-09-11 |
| Returned To Mfg | 2018-09-24 |
| Model Number | NA |
| Catalog Number | 706.52 |
| Lot Number | F138828 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-11 |