MAUDE Adverse Event Report: CAREFUSION, INC CROCODILE, SP, ERG TA; CROCODILE GRASPER

Model Number SP8364

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4); instrument is available for evaluation but end user has not returned sample for evaluation at this time.If further information becomes available a follow up medwatch will be submitted.

Event Description

The jaw would not grasp onto the gull bladder.Then the jaw broke off during surgery and a pin was missing during the case.There was no patient harm.Additional information provided 29mar2017: customer states there was no patient injury or intervention needed.The patient's medical status after the event was stable.The grasper assembly at the distal tip was disengaged from the hand piece while holding gall bladder.This was recovered using an additional grasper for removal.A small fragment/pin from the grasper assembly was not accounted for.Extensive irrigation and exploration was done by the surgeon, and no item was seen nor recovered.The patient did not require any additional medical procedure such as an x-ray.The procedure being performed was a laparoscopic cholecystectomy.The procedure was completed as planned.I would like to set up a visit with the rep of this area.I have called to set up a date and time for the grasper to be evaluated.At that time, i will return the grasper and parts to rep.Additional information from customer provided 29mar2017: customer states i wanted to make a correction on one of your questions.An x-ray was obtained and no item was noted in the reports.

Manufacturer Narrative

Additional information provided by customer determined this device was not involved in an event requiring fda reporting.

Event Description

On 08may2017 additional information from customer via telephone call: customer stated that email sent with additional information for this complaint is not correct and is associated with another reported complaint.Customer states the issue with this grasper was noted during a cholecystectomy, with no patient injury.He stated it was not grasping the gallbladder and they switched instruments.

• Brand Name: CROCODILE, SP, ERG TA
• Type of Device: CROCODILE GRASPER
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 5175 south royal atlanta dr; tucker GA 30084
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6460552
• MDR Text Key: 72176138
• Report Number: 1038548-2017-00110
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP8364
• Device Catalogue Number: SP8364
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other