MAUDE Adverse Event Report: PMI DISPOSABLE SUTURE PASSER

Model Number PMITCSG

Device Problems Bent (1059); Break (1069); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Event Description

Teeth on device were bent and defective.Broken piece had to be retrieved from patient.Progressive medical.

• Brand Name: PMI DISPOSABLE SUTURE PASSER
• Type of Device: PMI DISPOSABLE SUTURE PASSER
• MDR Report Key: 7446896
• MDR Text Key: 106247361
• Report Number: MW5076612
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMITCSG
• Device Lot Number: 004170807
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR