MAUDE Adverse Event Report: TELEFLEX HOL ML 5MM ENDO APPLIER

Catalog Number 544965

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

Alleged issue: doctor was removing an ovarian cyst when the clip did not release from the applier and actually tore the vessel.The staff tried to remove the clip after firing, but it did not release fro the applier.There was no injury or harm to the patient.Patient current condition reported as fine.

Manufacturer Narrative

Device sample received by manufacturer, but investigation is still underway at time of this report.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX; research triangle park NC
• Manufacturer Contact: jasmine brown ; p. o. box 12600; research triangle park, NC 27709 ; 9193614124
• MDR Report Key: 3866733
• MDR Text Key: 15122171
• Report Number: 1044475-2014-00111
• Device Sequence Number: 1
• Product Code: GDO
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/31/2014

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 Catalogue Number: 544965
• Device Lot Number: 3605250-010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1