MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-10 for FLEXIBLE LIGHT HANDLE COVER 26-012 manufactured by Deroyal Intercontinental, S.r.l..
[93092125]
Investigation summary a medwatch report ((b)(4)) was received reporting that a light handle cover (finished good 26-012, lot 44368851) split during use, contaminating the end user's sterile gloves. An internal complaint ((b)(4)) was entered as a result. No samples or photos of the reported issue were received for evaluation. The device history record was reviewed for discrepancies that may have contributed to the reported event. No such discrepancies were identified. A two-year review of sales and complaint history were reviewed for the finished good. A total of (b)(4) cases of 26-012 have been sold and 6 similar complaints have been filed. This yields a complaint-to-sales ratio of (b)(4). The raw material cover is supplied to deroyal by (b)(4). A supplier corrective action request (scar) was sent november 10, 2017 to (b)(4), and a response is due december 27, 2017. A review of the 2016-2017 scar logs was conducted and similar reports have been identified. The investigation is incomplete at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[93092126]
As the surgeon and surgical tech placed sterile light handle covers on or lights, both covers split and contaminated their sterile gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004605321-2017-00005 |
| MDR Report Key | 7017909 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-10 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-11-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 COVER |
| Generic Name | LIGHT, SURGICAL, ACCESSORIES |
| Product Code | FTA |
| Date Received | 2017-11-10 |
| Model Number | 26-012 |
| Lot Number | 44368851 |
| 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 | 2017-11-10 |