MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for DYNJ17487C manufactured by Medtronic.
[67128845]
Multiple attempts have been made to obtain additional details from the account by phone and email. The original report stated "there was a light glove that was placed onto a surgical light. When light glove was moved a split in the glove was detected and light glove was quarantined". It is unknown if this occurred during a procedure or during operating room set-up. It is unknown if this incident reached the patient or required any medical intervention. Medtronic is the manufacturer of this device and currently have initiated a recall on this device. Medtronic has been notified and will conduct an investigation. Due to the reported incident and in an abundance of caution this med watch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[67128846]
It was reported a light cover split when placed on a surgical light.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00002 |
| MDR Report Key | 6312590 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-10-12 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2017-02-08 |
| 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. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | LIGHT HANDLE COVER IN MAJOR ABDOMINAL PACK |
| Product Code | FDE |
| Date Received | 2017-02-08 |
| Catalog Number | DYNJ17487C |
| Lot Number | 16HD1132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 554325604 US 554325604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-08 |