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

Catalog Number 544965

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Alleged event: during use the applier was stuck.The surgeon tried to fire another clip but then the applier broke.Two clips were removed from the patient's stomach as well as a metallic piece that belonged to the applier.The patient's condition was reported as unknown.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The dhr for the instrument in question was reviewed and found completely without any irregularities.The returned instrument was evaluated and found that the jaws of the applier are in line with each other and not damaged or broken , as stated in complaint.Further evaluation of the returned instrument showed that this instrument picks-up, retains, closes and releases clips as required of its function both with the use of silastic test tubing and without.Parts were 100% visually inspected and tested at the manufacturing facility before instruments were sent to customer.No irregularities were found or reported at the time of processing and inspection of the product, as this is a standardized process for all instruments manufactured at this facility.At this time it is undetermined as to what caused the alleged defect since we were unable to duplicate the alleged issue.After further investigating the processes of manufacturing the instruments, all processes and procedures were followed.No corrective action required at this time.

Event Description

Alleged event: during use the applier was stuck.The surgeon tried to fire another clip but then the applier broke.Two clips were removed from the patient's stomach as well as a metallic piece that belonged to the applier.The patient's condition was reported as unknown.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709 785
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4874513
• MDR Text Key: 17216551
• Report Number: 3005236665-2015-00008
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1