MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-12-12 for CURVED MEMBRANE SCRAPER 338.27 manufactured by Alcon Grieshaber Ag.
[94533272]
No sample has been received by manufacturing for evaluation. 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
[94533273]
A physician reported that an ophthalmic membrane scrapper was used during a procedure in which a chipped part of the device was detected in the posterior segment of the patient's eye during a two week postop examination. The chipped part was surgically removed from the patient's eye. The patient's status was reported as recovered.
Patient Sequence No: 1, Text Type: D, B5
[110083973]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110083974]
Additional information received clarified that during a secondary procedure, the chipped part of the device was removed from the patient's eye. Corticosteroids, prourokinase and nsaids were administered. The patient's issue is again reported as resolved.
Patient Sequence No: 1, Text Type: D, B5
[112357503]
A sample was not received for evaluation. 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. A picture of the found and removed metal piece has been presented to the manufacturer. According to the details visible on the picture, the following statement can be given: the metal piece on the picture looks like the flex loop of the product as used during the surgical procedure. This flex loop is bonded into the instrument. Due to its geometry, the loop is slightly bent on the distal end. The loop on the picture of the complaint instrument shows an additional bending in the middle of its length which does not have its origin in production. Where this bending in the material comes from cannot be analyzed anymore. Important for the specific instrument is that it is inserted into the eye through the trocar in retracted position as described in the user manual. Otherwise, the loop will be damaged when pushed through the trocar. It can be assumed that the additional bending on the loop comes from the technique during the insertion of the instrument. If this would be the case, the bonding between the loop and the instrument could have been damaged during insertion in a non-retracted situation. After using the instrument, the loop might have been retracted into the instrument to take the instrument out of the eye. During this procedure the loop might have been lost in the eye. This is the only possible statement why the loop has been lost in the eye. Since this is a single case, no comparison can be made to get a more detailed understanding of this complaint. A detailed investigation could not be initiated. No sample arrived for investigation. No further actions will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003398873-2017-00032 |
| MDR Report Key | 7108622 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-12 |
| Date of Report | 2018-02-06 |
| Date of Event | 2017-11-14 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2017-01-02 |
| Date Added to Maude | 2017-12-12 |
| 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. NADIA BAILEY |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED MEMBRANE SCRAPER |
| Generic Name | SPATULA, OPHTHALMIC |
| Product Code | HND |
| Date Received | 2017-12-12 |
| Model Number | NA |
| Catalog Number | 338.27 |
| Lot Number | F145791 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-12 |