MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-11 for KITTNER DISSECTOR 28-0801 manufactured by Medsorb Dominicana, S.a..
[83126032]
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. (b)(4) supplies the dissector to deroyal industries. Therefore, a supplier corrective action request (scar) was issued to (b)(4) on july 24, 2017. As of the date of this report, a response has not yet been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated. Note: this report was submitted one day past the 30-day time frame due to an error in the electronic submission. This error was not noticed until the day after the report was submitted through the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83126033]
The cotton part on the end of the dissector came off in the patient. They were able to retrieve it with no problems or delays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2017-00009 |
| MDR Report Key | 6787676 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-11 |
| Date of Report | 2018-01-29 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2017-08-11 |
| 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 | 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 | KITTNER DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2017-08-11 |
| Model Number | 28-0801 |
| Lot Number | 45077546 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-08-11 |