MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for GRIESHABER REVOLUTION DSP SCISSORS 705.52P manufactured by Alcon Grieshaber Ag.
[55615449]
No sample has been received by manufacturing for evaluation. The investigation is in progress. 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 sample was released according to the manufacturer's 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55615450]
A doctor reported that an ophthalmic scissor tip was stuck with no action during surgery, but prior to any patient involvement. An alternate scissor tip was obtained in order to begin the procedure. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[60886881]
Corrected information is provided in brand name and model #/ lo # to clarify that the catalog number provided on the initial report was incorrect. The correct part number will be provided once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73355676]
A scissors sample was received by manufacturing with the original outer and inner blister including cover foil. The sample was visually inspected with the aid of a photomicroscope and with various magnifications. The scissors blade was broken. The instrument was destroyed in order to investigate why the blade broke off. The complaint history was reviewed two years back. It showed no comparable complaints. Per the manufacturing science and technology evaluation, the scissor blade was broken on an untypical position. Stresses in the scissors insert are most high at the end of the electrical discharge machining process cut, but the investigation showed that the scissors blade was broken there. The scissor blade was broken between the tip of the scissors and the end of the electrical discharge machining process cut. Since the scissor blade was not broken on the position with the most high stresses, the reason for the fracture had to be investigated. On the outer side of the scissor blades were signs of corrosion visible. The analysis of the cross section showed that the corrosion was entered into the scissor blade. The high stresses during activation led to the fracture of the scissor blade. A more detailed picture of the cross section shows how far corrosion already affected the scissor blade. The fine dark gray surface structure shows the corrosion is of the cross section. The rough surface (light gray) indicates where the cross section was not affected by corrosion. It can be concluded that corrosion led to the fracture of the scissor blade. Why the scissor started to corrode cannot be determined anymore. Corrosion affects the insert over time. However, the instrument passed all internal inspections. An insufficient process can be excluded since this complaint is a single case. Corrosion on a disposable instrument is very untypical. A re-use cannot be confirmed but not excluded. No injuries have been reported or are expected related to this issue. A manufacturing or design related root cause for the damage of the complained device has not been identified. Based on the complaint history the complaint represents a single event. No further actions will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003398873-2016-00016 |
| MDR Report Key | 5967157 |
| Date Received | 2016-09-21 |
| Date of Report | 2017-03-23 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2014-06-13 |
| Date Added to Maude | 2016-09-21 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| 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 | 2016-09-21 |
| Returned To Mfg | 2017-01-26 |
| Model Number | NA |
| Catalog Number | 705.52P |
| Lot Number | F112801 |
| Device Expiration Date | 2017-05-01 |
| 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 | 2016-09-21 |