MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-18 for BIOPSY SPECIALS BACK 89-9100 manufactured by Deroyal Industries, Inc..
[135185424]
Root cause: the scalpel contained in the convenience kit is supplied to deroyal by (b)(4). A supplier corrective action request (scar) was issued to (b)(4). In its response, the manufacturer stated that because the sample was not returned, the reported condition could not be confirmed. A precise root cause for the reported defect cannot be established. Possible root causes include equipment malfunction, equipment design, and ergonomics. Corrective action: in its scar response, (b)(4) stated a semi-automatic measurement system has been implemented to address the potential root causes for equipment malfunction and equipment design. A slide has been installed that sends rejected material to the scrap bin to address the potential root cause for ergonomics. A 100% "detachment test" also has been included in inspection. Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (finished good 89-9100, lot 47444549) that contained a scalpel that malfunctioned during use. The end user reported that the scalpel spring ejected the blade out of the back of the scalpel. The blunt end of the blade hit a physician in the upper arm. A sample was not returned for evaluation. Deroyal's complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event. No discrepancies were identified. The bill of materials for the kit was reviewed and the affected component was identified as raw material (b)(4), which is supplied to deroyal by (b)(4). The 2016-2018 scar and supplier notification letter logs were reviewed for similar complaints. No similar complaints were identified; however, due to the nature of the report, a scar was issued to (b)(4). A response was received january 14, 2019, and it was reviewed and accepted by deroyal's complaint investigator. Deroyal will continue to monitor post market feedback and will recognize if this issue reoccurs in the future. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[135185445]
The scalpel spring ejected the blade out the back of the scalpel, and the blunt end hit the physician on the upper arm. The scalpel was a component in a convenience kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00018 |
| MDR Report Key | 8261675 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2019-01-18 |
| 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 | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSY SPECIALS BACK |
| Generic Name | DISPOSABLE SURGICAL INSTRUMENT KIT |
| Product Code | KDD |
| Date Received | 2019-01-18 |
| Model Number | 89-9100 |
| Lot Number | 47444549 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-18 |