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 |