MAUDE Adverse Event Report: COOPERSURGICAL, INC. PIPELLE; ENDOMETRIAL PIPELLE

Model Number 8200

Device Problems Break (1069); Component Falling (1105); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

Complaint stated "the dr.Was using a pipeline on a patient.Dr.Noted the pipelle looked 'deformed' and possibly a piece broke off at the end of the pipelle and may be in the patient.".

Manufacturer Narrative

(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.A final report will be filed after customer follow up and investigation is complete.

• Brand Name: PIPELLE
• Type of Device: ENDOMETRIAL PIPELLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4491088
• MDR Text Key: 5345279
• Report Number: 1216677-2015-00002
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2015

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 Expiration Date: 10/31/2016
• Device Model Number: 8200
• Device Catalogue Number: 8200
• Device Lot Number: 138344
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/04/2015
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other