MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-24 for DYNJ38040A manufactured by Kirwan Surgical Products Llc.
[75854849]
It was reported that the plastic protector covering the tip is difficult to remove. This resulted in the tip becoming loose during the removal of the cover. The tip became dislodged from the cautery device during the procedure and made a tear in the patients' retina. It is unknown if the patient required any medical intervention. The sample has not been returned. Kirwan surgical products llc is the manufacturer of this device. Kirwan surgical products llc has been notified and will conduct an investigation and make the determination whether any corrective action is indicated. Due to the reported incident and in an abundance of caution this medwatch is being filed. Sample not returned.
Patient Sequence No: 1, Text Type: N, H10
[75854850]
It was reported the tip of the cautery device caused a patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00017 |
| MDR Report Key | 6587196 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date Mfgr Received | 2017-04-28 |
| Date Added to Maude | 2017-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CAUTERY DEVICE IN ACH VITRECTOMY PACK |
| Product Code | OJK |
| Date Received | 2017-05-24 |
| Catalog Number | DYNJ38040A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIRWAN SURGICAL PRODUCTS LLC |
| Manufacturer Address | 180 ENTERPRISE DR MARSHFIELD MA 02050 US 02050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-24 |