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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED MEDICAL DESIGN CO., LTD SUTURE PASSOR PRO; INSTRUMENT, LIGATURE PASSING AND KNOT TYING
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ADVANCED MEDICAL DESIGN CO., LTD SUTURE PASSOR PRO; INSTRUMENT, LIGATURE PASSING AND KNOT TYING Back to Search Results
Model Number RSG-14F
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/06/2018
Type of Reportable Event Malfunction
Event or Problem Description
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.
 
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Brand Name
SUTURE PASSOR PRO
Common Device Name
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
Manufacturer (Section D)
ADVANCED MEDICAL DESIGN CO., LTD
4f-5f, no29, wuquan 5th road,
wugu district,
new taipei city, r.o.c 24888
TW  24888
MDR Report Key7959014
Report Number3010570913-2018-00001
Device Sequence Number13801533
Product Code HCF
UDI-Device Identifier09349967000366
UDI-Public(01)09349967000366
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 10/11/2018
Report Date (Section F) 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/30/2020
Device Model NumberRSG-14F
Device Lot Number1726156
Was Device Available for Evaluation? No
Distributor Facility Aware Date10/02/2018
Event Location Hospital
Date Report to Manufacturer10/12/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/02/2018
Initial Report FDA Received Date10/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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