MAUDE Adverse Event Report: CAREFUSION, INC SERRATED CUP GRASPER, SP, ERG TA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SP94-8330

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available, a follow up medwatch will be submitted.

Event Description

The customer reported, the instrument jaw locked down on tissue during a procedure and would not unlock.A tool had to be used to release the jaws and the lap cholecystectomy was completed successfully.It was reported, no patient injury and patient did not require any additional medical procedures or interventions.

Manufacturer Narrative

(b)(4): one (1) sp94 ta handle device was returned for the instrument jaw locked down on tissue during a procedure and would not unlock.Visual and functional examination of the sp94 ta handle device confirmed the reported failure in that one of the ratchet components was completely broken off.Note the customer did return the grasper insert and tube device that was utilized when the device failure occurred.What the customer experienced was the jaw part locked when the ratchet component broke off.The broken ratchet failure was confirmed to be associated with the design of the ratchet.A project was initiated for the take apart product quality improvement which includes ta ratchet failures.Note: the device broken ratchet component was confirmed to be from the old design which was prior to the corrective actions in project were implemented.A review of the device history record did not reveal any non-conformances.The device passed all acceptance criteria for release.Conclusion(s): (b)(4) - product design / mechanical overstress the project identified the following probable root cause: the visual evaluation showed that the surface finish did not meet the drawing specifications.Fractures started on the inside of the hole reliefs at the bottom of deep grinding marks, most likely caused by improper manufacturing.The segregation lines created during cold rolling were cut 90 degrees to the direction of the hole relief slot.These lines are weak points in the material and may have contributed to the ratchet cam failures.Mechanical overstress in the user environment.Over-stressing can occur if the handle ratchets are engaged while the insert jaws are clamped shut on material and sudden force is placed on the ratchet cam to disengage.As a corrective action, bd has improved upon the design of the ratchet cam.A project was initiated for the take apart product quality improvement which includes ta ratchet failures.Bd will continue to trend and monitor for this reported failure.

• Brand Name: SERRATED CUP GRASPER, SP, ERG TA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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 ; 8473628063
• MDR Report Key: 5741532
• MDR Text Key: 47955839
• Report Number: 1038548-2016-00086
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP94-8330
• Device Lot Number: 854142 C13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1