MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-29 for RUBENSTEIN LRI DIAMOND KNIFE LONG HANDLE AK6160 manufactured by Accutome, Inc..
[17336752]
Diamond blade broke off of handle during phaco procedure. Blade was removed from the patient's eye immediately after in its entirety. No injury or complications to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[17432524]
Product was evaluated by accutome repair staff and it was concluded there were no observable manufacturer defects associated with the product. The blade observed was clearly broken and it does not appear that the blade "fell out" of the handle as originally reported. A break in the diamond blade could have been caused by a number of factors including mishandling, sterilization processes, or hitting the blade against other equipment during the procedure. There is no indication that the break was the product of a defect with the item.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2521877-2015-00001 |
| MDR Report Key | 4742402 |
| Report Source | 05 |
| Date Received | 2015-04-29 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-03-26 |
| Date Mfgr Received | 2015-04-16 |
| Date Added to Maude | 2015-06-11 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADAM PICKHOLTZ |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6108890200 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUBENSTEIN LRI DIAMOND KNIFE LONG HANDLE |
| Generic Name | DIAMOND KNIFE |
| Product Code | EMF |
| Date Received | 2015-04-29 |
| Returned To Mfg | 2015-04-16 |
| Model Number | AK6160 |
| Catalog Number | AK6160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUTOME, INC. |
| Manufacturer Address | 3222 PHOENIXVILLE PIKE MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-29 |