MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for GRIESHABER MAXGRIP FORCEPS, 23G 706.13 manufactured by Alcon Laboratories, Inc..
[177168455]
23g maxgrip forceps were opened to sterile field during surgery, and forceps would not close. New forceps were opened to sterile field, and the procedure was completed as planned with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9653050 |
| MDR Report Key | 9653050 |
| Date Received | 2020-01-31 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-11-27 |
| Report Date | 2019-12-19 |
| Date Reported to FDA | 2019-12-19 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIESHABER MAXGRIP FORCEPS, 23G |
| Generic Name | FORCEPS, OPHTHALMIC |
| Product Code | HNR |
| Date Received | 2020-01-31 |
| Model Number | 706.13 |
| Catalog Number | 706.13 |
| Lot Number | 302865M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |