MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-13 for SHARPOINT 72-2761 manufactured by Surgical Specialties Mexico.
[36349042]
All documents associated w/the production of the finished device were reviewed, such as incoming inspection results of raw material, production in-process inspections, final qa product inspections. ,m testing and acceptance criterial as well as any non-conformance which may have been noted during the receipt, production or release of the finished lot. There wasn't any non conformanc associated witht he production of this order. The exact cause cannot be determined, but the defect likely occurred due to a damaged blade. The damaged blade may occur during the manufacturing process as well as during custome rhandling and use. Description: slit knife full hdl-2. 75mm ang.
Patient Sequence No: 1, Text Type: N, H10
[36349043]
"the surgeon passed through the cornea w/the knife, he has to applied more pressure because of the dullness of the knife. The patient bleed and the surgeon has to suture the cornea. The patient went home. The patient did not stay longer in hospital because of that, he just did not get the surgery. The patient male (b)(6), was admitted in day surgery for a cataract surgery. For sure he never had the surgery he was in for. To insert the lens the patient has to wait 2-3 months, give time the cornea to heal, before going back to hospital and have the cataract surgery. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2015-00001 |
| MDR Report Key | 5369246 |
| Date Received | 2016-01-13 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-12-07 |
| Date Mfgr Received | 2015-12-07 |
| Device Manufacturer Date | 2015-07-25 |
| Date Added to Maude | 2016-01-15 |
| 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 ANGEL SOLIS |
| Manufacturer Street | CORREDOR TIJUANA ROSARITO 2000 EJIDO FRANCISCO VILLA # 24702 B |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22235 |
| Manufacturer Country | MX |
| Manufacturer Postal | 22235 |
| Manufacturer Phone | 6649691841 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHARPOINT |
| Product Code | EMF |
| Date Received | 2016-01-13 |
| Model Number | 72-2761 |
| Catalog Number | 72-2761 |
| Lot Number | MAKKG280, MAJG680, MAKP470 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES MEXICO |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 EJIDO FRANCISCO VILLA # 24702 B TIJUANA, BAJA CALIFORNIA 22235 MX 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-13 |