MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-21 for LAPAROSCOPIC KITTNER DISSECTOR 28-0801 manufactured by Medsorb Dominicana.
[70588074]
Investigation summary an internal complaint (b)(4) was received indicating that the kittner dissector separated from the applicator during use. The defective sample initially was reported to be available for evaluation. Due to the contamination of the sample, it was requested that pictures of the defective product be sent in lieu of the sample. As of the date of this report, no pictures have been received. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The raw material is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was issued to (b)(4). A response is due april 6, 2017. As of the date of this report, a response has not been received. The investigation is ongoing. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[70588075]
A kittner sponge came off the applicator while in use.
Patient Sequence No: 1, Text Type: D, B5
[73823271]
Root cause: the kittner dissector is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was issued to (b)(4). In its response, (b)(4) stated evidence suggests an incorrectly glued tip, not previously detected during 100 percent manual pull testing, may loosen and detach after additional handling or use. Corrective action: in its scar response, (b)(4) stated no new corrective actions are being taken as a result of the reported complaint. In response to previous reported failures of this nature, (b)(4) has clarified its manufacturing procedure and retrained all operators on the proper tip folding, gluing, and wrapping techniques. All current in-house material was manufactured after implementation/verification of these previous corrective actions. Investigation summary: an internal complaint ((b)(4)) was received indicating that the kittner dissector separated from the applicator during use. On april 3, deroyal received notice from the fda of a medwatch report (mw5068566) that was submitted. It was determined that the incident reported in the medwatch is the same incident reported in call (b)(4). The defective sample initially was reported to be available for evaluation. Due to the contamination of the sample, it was requested that pictures of the defective product be sent in lieu of the sample. As of the date of this report, no pictures have been received. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The raw material is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was issued to (b)(4) on february 23, 2017. A completed response was received march 28, 2017, and accepted by deroyal personnel on march 29, 2017. The raw material dissector has been on purchase inspection at deroyal since the first reported complaint for this issue. Each lot has been inspected with no non-conforming product found. Preventive action: in its scar response, (b)(4) stated the area supervisor will be monitoring operators to ensure the gluing process is performed correctly. The production inspector will continue to check all sticks for tip retention. 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
[73823272]
A kittner sponge came off the applicator while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2017-00005 |
| MDR Report Key | 6421299 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-21 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-22 |
| Date Added to Maude | 2017-03-21 |
| 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 | 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 | LAPAROSCOPIC KITTNER DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2017-03-21 |
| Model Number | 28-0801 |
| Lot Number | 43747905 |
| 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 |
| Manufacturer Address | ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS SAN PEDRO DE MACORI DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |