MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-11 for LAPAROSCOPIC KITTNER DISSECTOR 28-0801 manufactured by Medsorb Dominicana, S.a..
[64720074]
Investigation summary: an internal complaint (call (b)(4)) was received indicating the tip of a laparoscopic kittner dissector (part number 28-0801) came off the product during a procedure and was retrieved from the patient. The lot number has not been reported. Additionally, the defective product has not been returned for evaluation. In the initial report, the end user reported the sample was available for return; however, the end user discarded the product. Due to the absence of a lot number, the work order could not be reviewed for discrepancies that may have contributed to the reported event. (b)(4) supplies the dissector to deroyal industries. Therefore, a supplier corrective action request (scar) was issued to (b)(6) on january 3, 2017. A response is due february 15, 2017. As of the date of this report, a response has not been received. The 2014-2016 scar and supplier notification logs were reviewed for similar complaints. Similar complaints were identified for 2016. The investigation is incomplete at this time. This report will be updated when new and critical information is received.
Patient Sequence No: 1, Text Type: N, H10
[64720075]
During a lap chole procedure, the tip of the laparoscopic kittner came off. The tip was retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[65849625]
Root cause: the kittner dissector is supplied to deroyal by (b)(4). A supplier corrective action request (scar) was issued to (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 response, (b)(4) has identified the following corrective actions: add more details to the manufacturing procedure (manufacturing of endokittner pc3060 rev. Q) 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. All corrective actions were documented in (b)(4). Corrections: in the scar response, (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 were reinspected at 100 percent; deroyal returned lots 16f2326, 16h3290, 16d1367 and 16b0344 for reinspection at 100 percent. Investigation summary: an internal complaint ((b)(4)) was received indicating the tip of a laparoscopic kittner dissector (part number 28-0801) came off the product during a procedure and was retrieved from the patient. The lot number has not been reported. Additionally, the defective product has not been returned for evaluation. In the initial report, the end user reported the sample was available for return; however, the end user discarded the product. Due to the absence of a lot number, the work order could not be reviewed for discrepancies that may have contributed to the reported event. (b)(4) supplies the dissector to deroyal industries. Therefore, a supplier corrective action request (scar) was issued to (b)(4) on january 3, 2017. A response was received january 12, 2017 and accepted the same day. The 2014-2016 scar and supplier notification logs were reviewed for similar complaints. Similar complaints were identified for 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 response, (b)(4) stated the area supervisor followed up with each operator to ensure the gluing process is performed correctly. The production inspector will continue to check all sticks for tip retention. All preventive actions were documented in (b)(4). 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
[65849626]
During a lap chole procedure, the tip of the laparoscopic kittner came off. The tip was retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2017-00001 |
| MDR Report Key | 6243048 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-20 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-01-11 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPAROSCOPIC KITTNER DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2017-01-11 |
| Model Number | 28-0801 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 MACORI DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |