MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-12-14 for FLEXIBLE LIGHT HANDLE COVERS 26-012 manufactured by Deroyal Intercontinental, S.r.l..
[95798334]
Investigation summary: an internal complaint ((b)(4)) was received indicating a flexible light handle cover fell off a light during a procedure, compromising the sterile field. A defective sample was not available for return. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[95798335]
The flexible light handle covers (part number 26-012) are falling off the lights during procedures and compromising the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004605321-2017-00006 |
| MDR Report Key | 7118553 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-12-14 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-12-14 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Street | KM 7 AUTOPISTA JOAQUIN BALAGUE PISANO FREE ZONE, BUILDING 49 |
| Manufacturer City | SANTIAGO, SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE LIGHT HANDLE COVERS |
| Generic Name | LIGHT, SURGICAL, ACCESSORIES |
| Product Code | FTA |
| Date Received | 2017-12-14 |
| Model Number | 26-012 |
| Lot Number | 44992742 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Address | KM 7 AUTOPISTA JOAQUIN BALAGUE PISANO FREE ZONE BUILDING 49 SANTIAGO, SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-14 |