MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-24 for GRIESHABER SCISSORS/TIPS, UNSPECIFIED manufactured by Alcon Grieshaber Ag.
[48153593]
The investigation is in progress. The sample has not yet been received for evaluation. The device history record for the affected lot number was reviewed. No abnormalities that could have contributed to this event were found in the production documentation and the product was released according to the manufacturer's acceptance criteria. A 100% final inspection is performed for this product. A root cause has not been identified. The root cause will be stated when a sample has been analyzed. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[48153594]
A nurse reported that an ophthalmic scissors would not close after insertion into the eye during a pars plana vitrectomy and scleral buckle surgery. The expanded scissors had to be removed simultaneously with the entry port. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[54435497]
One scissor sample was received by manufacturing for evaluation. The sterile package, inner and outer blister, was received by manufacturing already opened. The sample was well protected with bubble wrap. The sample was visually inspected with the aid of a photomicroscope and with various magnifications. The sample was also functionally, destructively tested. The complaint history was reviewed two years back. It showed no comparable complaints related to similar devices. The customer complained that the scissor did not close during the surgery. The first visual inspection showed that the insert was most likely moved out of the handle. After approval for destructive testing the instrument was disassembled. Disassembling was performed in the way to investigate the connection between the insert and the handle and the free movement of the insert within the instrument tip. The insert with the extension tube is glued into the adjustment screw. This connection bond was investigated under the microscope. A glue collar was found on the adjustment screw indicating that the bond was glued adequately. The free movement worked well in the tip and tube of the instrument. As soon as the extension tube went through the gluing bond area (safety glue bond in the handle and the glue bond in the adjustment screw) a perceptible resistance was recognized. This indicates that both gluing bonds were glued adequately. A misalignment of the passage for the insert through the tube, tip, screw, handle and adjustment screw was investigated. Since the insert with adjustment screw moved easy through it, a misalignment can be excluded. The screw in the tip of the instrument was investigated for manufacturing burrs. No burrs influencing the mechanism of the instrument were found. The investigation confirmed the customer complained. The insert moved out of the instrument and could not be activated anymore. The investigation confirmed that the instrument was built according to the process. As no deviation to the manufacturing process was identified, the reason for this fail could not be determine within this investigation. As no similar complaints were observed and the complaint rate is within an acceptable range, this complaint is considered as single event and no further actions will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003398873-2016-00009 |
| MDR Report Key | 5748452 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-24 |
| Date of Report | 2016-09-11 |
| Date of Event | 2016-06-07 |
| Date Mfgr Received | 2016-08-25 |
| Device Manufacturer Date | 2015-08-12 |
| Date Added to Maude | 2016-06-24 |
| 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. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON GRIESHABER AG |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN 8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8203 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIESHABER SCISSORS/TIPS, UNSPECIFIED |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | HNF |
| Date Received | 2016-06-24 |
| Returned To Mfg | 2016-07-01 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | F129861 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2016-06-24 |