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

Catalog Number 544965

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleged event: the clips could not be locked.Clips fell into the patient's body but were removed.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Per lot number provided on the complaint form, the device history record (dhr) for the instrument in question was reviewed and found complete ly without any irregularities.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause.All instruments are thoroughly visually inspected and function tested at time of manufacture.No corrective action required at this time.

Event Description

Alleged event: the clips could not be locked.Clips fell into the patient's body but were removed.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The returned instrument was evaluated and found that the jaws are aligned with each other and that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.During the evaluation it was noted that this instrument has a non oem flush port cap installed on it.We are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.Parts were 100% visually inspected and tested at the manufacturing facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.No corrective action required at this time.

Event Description

Alleged event: the clips could not be locked.Clips fell into the patient's body but were removed.The patient's condition was reported as fine.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5097016
• MDR Text Key: 26768484
• Report Number: 1044475-2015-00368
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06B1498877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1