MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-06 for GRIESHABER REVOLUTION DSP SCISSORS 705.52P manufactured by Alcon Grieshaber Ag.
[72207630]
A sample is available that has not yet 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 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
[72207631]
A materials manager reported that a pair of ophthalmic scissors would not work when the package was opened prior to surgery. An alternate pair of scissors was obtained prior to starting the procedure. There was no patient involvement with the unsatisfactory scissors.
Patient Sequence No: 1, Text Type: D, B5
[86924745]
The customer returned a sample of disposable curved scissors to manufacturing for evaluation. The sample was received inside of a plastic bag. The tip was protected with foam. The sample was visually inspected. The customer? S complaint was confirmed. It was not able to close the instrument. The sample has been destructively investigated. The first inspection showed that the insert and the extension tube were no longer fixed in the handle. The assumption was that no glue would be found on the shaft and in the handle, but the investigation shows glue residuals on the appropriate position in the handle. This demonstrates that the gluing process was applied appropriately. The stability of the gluing process for the extension tube was investigated in the vd-252-a. It was investigated if there is any influence on the gluing process which might reduce the final quality. No negative influence was found therefore, the gluing process can be considered as a stable and safe process. The destructive investigation did not determine the cause of the complaint. It is clear that the connection between the insert and the handle failed, but the root cause could not be identified. Due to the sign of use, the scissors worked once otherwise it is not possible to get in to the trocar cannula. This is the sixth complaint for this kind of issue in the last two years. No further actions are issued. The manufacturer internal reference number is: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003398873-2017-00006 |
| MDR Report Key | 6463376 |
| Date Received | 2017-04-06 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-05-29 |
| Device Manufacturer Date | 2016-05-24 |
| Date Added to Maude | 2017-04-06 |
| 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 | 2017-04-06 |
| Returned To Mfg | 2017-04-24 |
| Model Number | NA |
| Catalog Number | 705.52P |
| Lot Number | F137903 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2017-04-06 |