MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for GRIESHABER REVOLUTION DSP SCISSORS 706.52 manufactured by Alcon Grieshaber Ag.
[132076909]
No sample has been received by manufacturing for evaluation. The device history record for the affected lot was reviewed. No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to acceptance criteria. A 100% final inspection is performed for this product. 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
[132076910]
An operating room manager reported that an ophthalmic scissors tip broke off inside of a patient's left eye during a vitrectomy with membrane peel surgery. The broken tip was successfully removed from the patient's eye during the same procedure. There was no impact to the patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2019-00001 |
| MDR Report Key | 8208834 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2018-08-06 |
| Date Added to Maude | 2019-01-02 |
| 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 | MS. CINDY MILAM |
| 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 | 2019-01-02 |
| Model Number | NA |
| Catalog Number | 706.52 |
| Lot Number | F165007 |
| 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 | 2019-01-02 |