MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-10 for KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4" 30-101 manufactured by Deroyal Guatemala.
[5106837]
During use of the kittner dissector, sponge broke down while in use on pt. The blue x-ray string flaked off in the pt during surgery.
Patient Sequence No: 1, Text Type: D, B5
[12519337]
Investigation findings: the qfi report was reviewed to obtain the sales and similar complaint info. (b)(4). Similar reports have been identified. The work order was reviewed for discrepancies. Discrepancies were identified. Raw material (b)(4), lot number 1187971, 1189318 and 1192423 was utilized within the finished good. The raw material is a vendor supplied product. The 2012, 2013 and 2014 scar logs were reviewed to identify if similar reports were identified. The raw material is supplied to deroyal by (b)(4). The vendor was issued (b)(4). The vendor has been notified that the sample will not be returned to deroyal for eval. Follow-up was performed on 10/24/2014 to alert the vendor of the approaching due date. The vendor supplied the response on 10/27/2014. During the previous investigations for similar complaints, the qc complaint specialist requested additional info in reference to the previous scar corrective action. Previous samples were received and it was identified that the stitching on the kittner to keep the device closed was not fully secured. This allowed the kittner to unravel and the x-ray element to fall out. Pictures of those samples have been provided to the vendor in addition to the actual samples. In addition to the vendor investigation a joint investigation was conducted with the qc of the mfg facility. As part of the offshore investigation an in-house inspection was done over the raw material(b)(4) and no issue was found from lot 1217474. Assembly personnel have been informed of the issue and to avoid assembly problems, they have to make sure to place correctly all the components in the work order. Also, if there is any defective material they need to document and sent samples to qc to be forwarded as needed. Correction: a replacement has been provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2014-00023 |
| MDR Report Key | 4254211 |
| Report Source | 05 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-11-10 |
| Date of Event | 2014-09-30 |
| Date Facility Aware | 2014-09-30 |
| Report Date | 2014-11-10 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-12-08 |
| 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 Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622333 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4" |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLAST |
| Product Code | GDI |
| Date Received | 2014-11-10 |
| Catalog Number | 30-101 |
| Lot Number | 35935666 |
| Device Expiration Date | 2019-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |