MAUDE Adverse Event Report: CAREFUSION, INC NON-RATCHETED HANDLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SP95

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a trial with the 3mm maryland, while using the bovi, dr.(b)(6) noticed that the instrument was not working correctly as the energy was getting to the tip of the instrument.It smelt like something was burning and when the instrument was taken out of the trocar the instrument shaft was melted and there was soot in the trocar.After the case, where the trocar had been, the patient had a burn.Instrument had been used previously at facility and worked fine.Patient was burned at incision area where product at, no medical intervention required, no user harm.The device was under current for 10 minuets, the device was inserted through the trocar and was being held by dr.(b)(6).The event was resolved by removing the device from the facility and sending it in {for investigation}.The hernia procedure was completed as planned.Although additional questions were asked, nothing further was answered.This record captures the sp95 that had been used in the event.

Manufacturer Narrative

(b)(4).Manufacture date: december 2014.One (1) non-ratcheted handle was returned as the complaint sample.The lot code was etched normally and displayed as l14 (dec 2014).Upon initial visual inspections, light usage marks were noted as minor scuffs and scratches on the handle surfaces.Overall the sample appeared to be new with very few usage marks and an almost like new appearance.At initial review, no major signs of damages, broken pieces, cracking or heat-related issues were noted.The sample was returned as a whole with no missing or extra pieces.Furthermore, the rotation knob displayed normal characteristics with screws and black buttons intact and functional.Per complaint description, it was concluded that tube-shaft incurred the damages and failed during the event, this tube-shaft part mates with the handle and was suspected to be a competitor product; it was not sent in for evaluations.The sample sent in was the handle, it was a part of the failure event and did not incur any damages as a result.Further functional checks were performed of the handle sample to verify conformance and normal functioning when mated with in-house sample tube-shafts.First, the handle mated normally with an insert and tube, it held in place when pushed into the black-button activated shutters within the handle.Next, with the tube in place, the rotating knob pivoted through the eight distinct detent points within the 360 degree rotation.Next, the assembled sample was verified for proper insulation using the high-potential (hi-pot) electrical test.Electrical test currents were ran through the handle¿s bovie post to the tips, it is performed by attaching the electrical potential end to the bovie post and the electrical receiving end on an outer metal tube.The sample assembly was noted to be completely insulated at points in between; no electrical currents were noted to pass through the length of the tube shaft and handle.Based on the visual and functional inspections of the sp95 handle, the reported failure mode was not confirmed.It is possible the cause of failure was due to the tube-shaft used, however this cannot be confirmed due to part not received for evaluations.Conclusion(s): root cause ¿ failure not confirmed ¿ no issues noted with sample.The sample sent in was the unaffected part of the failure event, and no collateral damages from the event were noted.Further functional checks and hi-pot tests were performed of the handle sample to verify conformance and normal functioning when mated with in-house sample tube-grasper tip components.The sample assembly was noted to be completely insulated at points in between; no electrical currents were noted to pass through the length of the tube shaft and handle.It is possible the cause of failure was due to the tube-shaft used, however this cannot be confirmed due to part not received for evaluations.

• Brand Name: NON-RATCHETED HANDLE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061
• MDR Report Key: 7488531
• MDR Text Key: 107446911
• Report Number: 1923569-2018-00009
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP95
• Device Lot Number: L14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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