MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for GRIESHABER REVOLUTION DSP SCISSORS 705.52P manufactured by Alcon Grieshaber Ag.
[128901898]
The received scissors sample was received in the opened, original packaging including the cover foil. The sample shows signs of use due to surgery residuals. The sample was visually inspected with the aid of a photomicroscope with various magnifications. The scissor could not be activated because of surgery residuals. After cleaning, it could be activated, but stuck in the closed position because the extension tube moves forward. The customer? S complaint was confirmed. It was found that the tube is loose and blocks the scissor by activating. The device history record for the affected lot was reviewed. No abnormalities that could have contributed to this event were found and the product was released according to acceptance criteria. A 100% final inspection is performed for this product. The complaint history was reviewed two years back. It showed one comparable complaint. No adverse trend observed. It cannot be excluded that the metal tube loosened and therefore, a proper activation was no longer possible. This kind of damage was already detected and investigated. The root cause could not be identified conclusively, but the most likely root cause can be determined to be an improperly performed bonding procedure. Based on the available data this is a single event for this finished product lot. The currently valid risk analysis considers the possible risks related to the reported event. With this single case and one related complaint within a time range of 24 months, the likelihood of occurrence of the hazard that may cause a patient harm is assessed in the risk management report. The final risk is considered as low, remains unchanged and at an acceptable level. Future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128901899]
A physician reported that an ophthalmic scissors device kept its tip in the closed position prior to surgery. An alternate scissors was obtained in order to subsequently begin and complete the procedure. As there was no contact between the unsatisfactory scissors and the patient, there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003398873-2018-00039 |
| MDR Report Key | 8115772 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2016-08-17 |
| Date Added to Maude | 2018-11-29 |
| 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. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 | 0 |
| Brand Name | GRIESHABER REVOLUTION DSP SCISSORS |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | HNF |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-11-19 |
| Model Number | NA |
| Catalog Number | 705.52P |
| Lot Number | F140797 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-11-29 |