MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO 5 ML; APPLIER

Catalog Number 543965

Device Problems Unintended Ejection (1234); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

Alleged event: after several times of firing, the remaining hem-o-lok clips in the device dropped into the pt's body.The pt's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The device sample has not been returned for investigation at the time of this report.The mfr will continue to monitor nad trend related events.

• Brand Name: AUTO ENDO 5 ML
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: effie jefferson, regulatory aff ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4771457
• MDR Text Key: 5792952
• Report Number: 3003898360-2015-00354
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2015

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: Other
• Device Expiration Date: 05/29/2017
• Device Catalogue Number: 543965
• Device Lot Number: 73E1400447
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1