MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for OUTER TUBE LIL-TU-31 manufactured by Ab Medica Sas.
[186724093]
The second product code for this device is gei. The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[186724094]
The customer reported that the device, lil-tu-31, was being used during an unknown type of procedure on (b)(6) 2020 when it was reported that energy breached the shaft of the instrument and caused a minor burn at the port site of the cannula. The patient sustained and unknown degree of burn. The procedure had been completed successfully and the doctor stated that the patient was "okay". Further assessment information has been requested; however, at this time there has been no further information reported to the facility's sales representative who has attempted to gain the information. This report is being raised on the basis of injury due to an unknown degree of burn to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00138 |
| MDR Report Key | 9865108 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-23 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995358 |
| Manufacturer G1 | AB MEDICA SAS |
| Manufacturer Street | AU CAPITAL DE 300000 LES PETITES QUARTEREES |
| Manufacturer City | MER SUR CHER, 18100 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 18100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTER TUBE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-23 |
| Catalog Number | LIL-TU-31 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AB MEDICA SAS |
| Manufacturer Address | AU CAPITAL DE 300000 LES PETITES QUARTEREES MER SUR CHER, 18100 FR 18100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |