MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-07 for GRIESHABER REVOLUTION DSP SCISSORS 706.52 manufactured by Alcon Grieshaber Ag.
[183118483]
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
[183118484]
A customer reported that during a surgical procedure the surgeon noted that the micro-scissors were damaged. The surgeon was able to remove the scissors form the patient's eye before it broke. Additional information has been received indicating the doctor inserted the scissors through the trocar and noticed that they were broken before he used them. He very carefully removed the instrument from the eye without it breaking in the eye. Once it was removed, one side of the scissors broke off. The surgeon proceeded to remove the scissors and the broken piece off the surgical field, retrieved the package and replaced with another disposable scissors. The case was completed with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2020-00007 |
| MDR Report Key | 9557164 |
| Report Source | OTHER |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-01-04 |
| Date Added to Maude | 2020-01-07 |
| 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. 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 SCISSORS |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | HNF |
| Date Received | 2020-01-07 |
| Model Number | NA |
| Catalog Number | 706.52 |
| Lot Number | F173275 |
| 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 | 2020-01-07 |