MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; APPLIER

Catalog Number 543965

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2015

Event Type  malfunction  

Event Description

Complaint alleges that the applier only fired once and then stopped working.Another applier was used to finish the case.No patient injury reported.Patient current condition is fine.

Manufacturer Narrative

(b)(4).Device history record (dhr) investigation did not show issues related to this complaint.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.

Manufacturer Narrative

(b)(4).One (1) applier of catalog number 543965 auto endo5 ml was received used, opened without original package, lot # 73l1400313 was confirmed with sample received.During visual inspection it was observed that the jaw components are damaged, one stuck clip in jaws, trigger is pre-activated, and knob component is lightly misaligned.Functional inspection: stuck clip in jaws was removed; clip hard to remove, despite the sample condition; jaw damaged & knob component misaligned.Although; from the sample received it was observed that the defect reported by the customer "fired only once" during visual & functional inspections, the root cause for this issue is considered unknown, since the knob & jaws components are damaged.A corrective action cannot be established due to the fact of the sample condition.In addition, all products are 100% tested by manufacturer and this defect would have been detected during the functional testing.

Event Description

Complaint alleges that the applier only fired once and then stopped working.Another applier was used to finish the case.No patient injury reported.Patient current condition is fine.

• Brand Name: AUTO ENDO5 ML
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4688242
• MDR Text Key: 5715598
• Report Number: 3003898360-2015-00266
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/17/2017
• Device Catalogue Number: 543965
• Device Lot Number: 73L1400313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1