MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for SUTURE PASSOR PRO RSG-14F manufactured by Advanced Medical Design Co., Ltd.
[125443668]
Patient Sequence No: 1, Text Type: N, H10
[125443669]
Fda report (b)(4): doctor called from his office. Stated that he had removed the shaft from a patient who had surgery in short stay one month prior. Additional information: the device did not cause serious injury to the patient but it did require the piece to be removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010570913-2018-00001 |
| MDR Report Key | 7959014 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-06-06 |
| Date Facility Aware | 2018-10-02 |
| Report Date | 2018-10-12 |
| Date Reported to Mfgr | 2018-10-12 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-10-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SHIAU TAN |
| Manufacturer Street | 1625 SOUTH TACOMA WAY |
| Manufacturer City | TACOMA WA 98409 |
| Manufacturer Country | US |
| Manufacturer Postal | 98409 |
| Manufacturer Phone | 2534416534 |
| Manufacturer G1 | ADVANCED MEDICAL DESIGN CO., LTD |
| Manufacturer Street | 4F-5F, NO. 29 WUQUAN 5TH RD., WUGU DIST., |
| Manufacturer City | NEW TAIPEI CITY, R.O.C 24888 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 24888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUTURE PASSOR PRO |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2018-10-11 |
| Model Number | RSG-14F |
| Lot Number | 1726156 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED MEDICAL DESIGN CO., LTD |
| Manufacturer Address | 4F-5F, NO29, WUQUAN 5TH ROAD, WUGU DISTRICT, NEW TAIPEI CITY, R.O.C 24888 TW 24888 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-11 |