MAUDE Adverse Event Report: ADVANCED MEDICAL DESIGN CO., LTD SUTURE PASSOR PRO; INSTRUMENT, LIGATURE PASSING AND KNOT TYING,

Model Number	RSG-14F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
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.

• 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, taipei 24888 ; TW 24888
• MDR Report Key: 11271453
• Report Number: 3010570913-2018-00003
• Device Sequence Number: 19890881
• Product Code: HCF
• UDI-Device Identifier: 09349967000366
• UDI-Public: (01)09349967000366
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/03/2021
• Report Date (Section F): 09/11/2018

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 Date: 12/30/2020
• Device Model Number: RSG-14F
• Device Lot Number: 1726156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 09/11/2018