MAUDE Adverse Event Report: TELEFLEX HOC PLUS ENDOTOUCH APPLIER 13" CVD; ENDO APPLIER

Catalog Number 114527

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

It was reported that the applier didn't load the clip properly, which caused it to fall.It is unk at what point the clip fell.No reported pt injury.Pt current condition is fine.

Manufacturer Narrative

Device sample received by the mfr, but investigation is still on-going.

• Brand Name: HOC PLUS ENDOTOUCH APPLIER 13" CVD
• Type of Device: ENDO APPLIER
• Manufacturer (Section D): TELEFLEX; research triangle park NC
• Manufacturer (Section G): TELEFLEX
• Manufacturer Contact: elaine burkle, rn ; po box 12600; rtp, NC 27709 ; 9194334957
• MDR Report Key: 3909808
• MDR Text Key: 4490863
• Report Number: 1044475-2014-00034
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/05/2014

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: 114527
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 02/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1