MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 4.0 ULTEM KOH-EFF

Model Number AD750-KE40

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

The balloon popped during the procure.Had to open and use a new one to complete the test.Returning 1 single manipulator for credit.And returning in a bio hazard bag.Ref e-complaint (b)(4).1216677-2020-00253 sterile 4-0 ultem koh-eff ad750-ke40 e-complaint (b)(4).

• Brand Name: STERILE 4.0 ULTEM KOH-EFF
• Type of Device: STERILE 4.0 ULTEM KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 10801992
• MDR Text Key: 249644685
• Report Number: 1216677-2020-00253
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AD750-KE40
• Device Catalogue Number: AD750-KE40
• Device Lot Number: 274803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other