MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-11-23 for KITTNER DISSECTOR 28-0801 manufactured by Medsorb Dominicana, S.a..
[60763309]
Root cause: the raw material is supplied to deroyal industries, inc. By (b)(4). Therefore, a supplier corrective action request (scar) was issued to the (b)(4). In its response, (b)(4) stated its investigation determined some glue operators used a slightly varied method of wrapping tape on the end of the stick. This variation left the potential for glue to be in the incorrect area of the tape. Additionally, a gap was identified in the training of operators who had been in the position for less than 1 year. Corrective action: in the scar, (b)(4) has identified the following corrective actions: add more details to the manufacturing procedure (manufacturing of endokittner (b)(4)) to clarify the steps of the gluing process; retrain all operators on proper tip folding, gluing, and wrapping techniques; and supervisor will follow-up to ensure all operators are trained on the manufacturing procedure and related quality documentation. Corrections: in the scar, (b)(4) has stated personnel involved were notified through written notification about the non-conformity; inventory verification at the (b)(4) warehouse was performed and lots 4k303 and 16h3290 will be reinspected at 100%; deroyal will return lots 16f2326, 16h3290, 16d1367, and 16b0344 to (b)(4) for reinspection at 100%. Investigation summary: an internal complaint ((b)(4)) was received indicating that the sponge tip of a kittner dissector ((b)(4)) had fallen into a patient during a procedure. A lot number was not reported. The potential lot numbers were reviewed and no discrepancies that may have contributed to the reported issue were identified. (b)(4) is used within finished (b)(4). The raw material is supplied by (b)(4). The 2014-2016 scar and supplier notification letter (snl) logs were reviewed for similar complaints. Similar complaints were identified in 2016. A scar was issued to (b)(4) and a response was received november 21, 2016. As a result of the vendor investigation, deroyal has placed the product under purchase inspection and assigned verification of the complaint. Preventive action: in the scar, (b)(4) has stated the area supervisor will be monitoring each operator to ensure the gluing process is performed correctly. The production inspector will continue to check all sticks for tip retention. The investigation is complete. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[60763310]
Sponge at the tip fell into patient during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2016-00023 |
| MDR Report Key | 6124009 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-10-21 |
| Date Mfgr Received | 2016-10-26 |
| Date Added to Maude | 2016-11-23 |
| 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 | ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1595 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 | 3 |
| Brand Name | KITTNER DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2016-11-23 |
| Model Number | 28-0801 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSORB DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORIS, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |