MAUDE Adverse Event Report: TELEFLEX MEDICAL 5MM JOHANS GRASPER; ELECTROSURGICAL,CUTTING&COAGULATION

Catalog Number PCVJG5

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual inspection was performed under microscope confirming damage to the internal lock tube of the shaft.Tear down of the shaft assemblies was performed to confirm observations.Two grasper tool tips were returned with the shaft and both functioned properly.The reason the tool tips fell off during the procedure was due to the lock tube security was compromised and could not lock the mechanical tool tip as designed.The device history review for the product 5mm johans grasper, lot #73m1500300 investigations did not show issues related to the complaint.The root cause is the instrument was not used correctly during attaching and removal of the mechanical tool tip resulting in breaking the lock tube.No corrective action at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The johan grasper fell off of a shaft and into the patient's abdomen.This happened two times during the procedure.The tool tip was retrieved laparoscopically.The patient's condition was reported as fine.

• Brand Name: 5MM JOHANS GRASPER
• Type of Device: ELECTROSURGICAL,CUTTING&COAGULATION
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5887039
• MDR Text Key: 52500229
• Report Number: 3003898360-2016-00772
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K153063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2018
• Device Catalogue Number: PCVJG5
• Device Lot Number: 73M1500300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1