MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-09 for IRIS RETRACTORS 40.02-6 manufactured by Synergetics, Inc..
[3308708]
Title: (b)(4). Event desc: 2 iris retractors broke inside the eye when the surgeon was putting it in. He was using this to open the pupil. The surgeon states he was able to retrieve all the broken pieces. The surgeon spoke with the mfr about this product. Device usage problem. Device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
[10418000]
(b)(4), medwatch mfr report number 9005675-2010-00001. Summary: synergetics could not determine a root cause of the reported complaint. This complaint is considered a malfunction of the device to perform its intended use. The device was not returned for evaluation. Calls to the complainant were not returned to determine where the break of the iris retractors occurred. The iris retractors are made from the same material used to mfr sutures, nylon, and comply with usp requirements for tensile strength which is designed to minimize any breakage during use. Based on the info contained or referenced in this report, synergetics considers this complaint to be an isolated occurrence and will monitor this complaint for future corrective and preventive action. This complaint was clearly a malfunction in the device failed to meet its performance specification. However, as the device was not returned and the complainant could not be reached to obtain further info, it is unlikely the malfunction would have resulted in death, serious injury or other significant adverse event experience. If the iris retractor did break, the retractor should be able to be removed with vitreoretinal ophthalmic forceps. It is unk whether another set of iris retractors were used after the first set of iris retractors broke and what was the final result of the surgery. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932402-2010-00001 |
| MDR Report Key | 2923401 |
| Report Source | 05,06 |
| Date Received | 2010-12-09 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-11-02 |
| Report Date | 2010-11-01 |
| Date Reported to FDA | 2010-11-01 |
| Date Mfgr Received | 2010-11-02 |
| Date Added to Maude | 2013-01-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal | 63368 |
| Manufacturer Phone | 6367945107 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIS RETRACTORS |
| Generic Name | DISPOSABLE FLEXIBLE IRIS RETRACTOR |
| Product Code | GZX |
| Date Received | 2010-12-09 |
| Model Number | 40.02-6 |
| Lot Number | 9010411 |
| Device Expiration Date | 2012-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS, INC. |
| Manufacturer Address | 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-09 |