MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-13 for GRIESHABER REVOLUTION DSP SCISSORS 706.52 manufactured by Alcon Grieshaber Ag.
[183118700]
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
[183118701]
A nurse reported that an ophthalmic scissors tip broke and separated while inside of the patient's eye during surgery. An alternate device was obtained in order to retrieve the broken scissors part from the eye. There was no harm to the patient. Additional information received further clarified that an enlarged incision was created in order to successfully remove the broken scissors part from the patient's eye. The procedure being performed was a vitrectomy. An alternate, third scissors tip was obtained in order to successfully complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2020-00008 |
| MDR Report Key | 9581097 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2020-01-13 |
| 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. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| 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 | 2020-01-13 |
| Model Number | NA |
| Catalog Number | 706.52 |
| Lot Number | F172769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-13 |