MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for LIGHT HANDLE COVER 26-011NS manufactured by Brentwood Industries, Inc..
[120107936]
Root cause: the raw material cover is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was issued to (b)(4). In its response, the supplier stated it was unable to determine a root cause for the reported issue. No evidence of the reported condition was found during (b)(4) manufacturing process. Parts are inspected for fitment using the same light handle. Detection of the defect is not possible due to the low frequency of the reported issue - 1 part out of (b)(4). No sample was returned for evaluation of fit with the inspection handle. Corrective action: the supplier stated in its scar response that it will continue to follow procedures outlined for inspection frequency of the product fit. It will continue to monitor product during production utilizing the inspection plan and go/no-go gauges that are required for the product. Investigation summary: an internal complaint (b)(4) was received indicating that a light handle cover (finished good (b)(4), lot #rj00050063) fell into the sterile field during surgery. The defective sample was not available for return. The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event. None were identified. Lot mapping identified the affected raw material item as 4-9542-1 (lot #rj00050063), which is supplied to deroyal by (b)(4). The 2015-2017 scar and supplier notification letter logs were reviewed for similar complaints. Similar complaints were identified; therefore, scar (b)(4) was issued to (b)(4). A response has been received. Deroyal has sold (b)(4) cases of the finished good from november 9, 2016, to august 13, 2018. Each case contains (b)(4) eaches, which equates to (b)(4) eaches sold. Only 8 similar complaints were identified, producing a complaint-to-sales ratio of (b)(4). A corporate corrective and preventive action plan ((b)(4)) was opened to investigate reports of light handle covers cracking and/or falling during use. It was determined through this capa that the number of complaints to selling unit of measure was extremely low and complaints would be monitored on a one-on-one basis. Deroyal will continue to monitor post market feedback and will recognize in the future if the issue reoccurs. Preventive action: a preventive action has not been taken. The investigation is complete. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[120107937]
The light handle cover fell down into the sterile field during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2018-00004 |
| MDR Report Key | 7852574 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-09-06 |
| 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 INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT HANDLE COVER |
| Generic Name | LIGHT, SURGICAL, ACCESSORIES |
| Product Code | FTA |
| Date Received | 2018-09-06 |
| Model Number | 26-011NS |
| Lot Number | RJ00050063 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRENTWOOD INDUSTRIES, INC. |
| Manufacturer Address | 621 BRENTWOOD DR READING PA 19611 US 19611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |