MAUDE Adverse Event Report: CONMED LINVATEC INSUFFLATOR 40L WARM READY; INSUFFLATOR, LAPAROSCOPIC

Catalog Number GS1002

Device Problem Pressure Problem (3012)

Patient Problem Cardiac Arrest (1762)

Event Date 10/28/2014

Event Type  Injury  

Event Description

On (b)(4) 2014, conmed received a product report from the end user facility via its sales representative, which indicated a "rapid and massive fluctuation of pressure during a lap case.Patient had a cardiac event and may be related to the fluctuating pressure".Follow-up with the representative and the user facility was immediately conducted and received information revealed the mentioned incident had reportedly occurred on or about (b)(6) 2014 and the investigation into this reported adverse event and its findings are as follows: a review of the service/repair requests revealed that following a d&c hysteroscopy and diagnostic laparoscopy procedure presumably on (b)(6) 2014, the hospital returned gs1002 insufflator on (b)(6) 2014 for evaluation/repair with the customer complaint comment listed as "pressure fluctuating" in the complaint system.Reportedly, a letter from the biomed service repair department at the user facility dated (b)(6) 2014 contained the information that the patient had experienced a cardiac event was supposedly attached to the unit.There is no documentation indicating that the letter was attached to the unit when received by the local service center.The unit was returned to the manufacturer, where testing results indicated that the complaint could not be duplicated/verified as testing showed the unit performed as intended with no problems or abnormalities noted, other than the power switch illumination was dim.This reported problem was therefore unknowingly processed as per routine complaint/service procedure at the time.On (b)(6) 2014, the hospital allegedly experienced additional pressure issues with another gs1002 insufflator (serial # (b)(4)) and reported that the "unit was not alarming 'overpressure'", this unit was also returned to the manufacturer where testing results showed the reported problem could not be duplicated/verified, as the unit performed as intended with no "overpressure" problem or any abnormalities noted.Subsequently, on (b)(6) 2014 the hospital once again reported "pressure was rapidly fluctuating as high as 50mmhg" on a 3rd gs1002 (serial (b)(4)).This unit is being returned to manufacturer, but not yet tested.However, accompanying this 3rd complaint report received by conmed on (b)(4) 2014 was an indication that during the 1st event allegedly on (b)( 6) 2014, the gs1002 with serial (b)(4) was involved in an incident, where the patient went into cardiac arrest and that during this event, surgery ceased and cpr was successfully administered.Immediately after learning of this event, an investigation was conducted and the legal manufacturer of the device was also informed.Based on received information, the intended surgery was unable to be completed and has yet to be rescheduled.However, hospital records indicate that the patient is currently doing well.

Manufacturer Narrative

The legal manufacturer was advised; the device associated with the "cardiac event" was returned to the physical manufacturer for evaluation.Testing results as of this filing showed no problems or abnormalities noted (other than a dim power switch light).The alleged "fluctuating pressure when in use" therefore, could not be verified.This gs1002, serial (b)(4) was supplied to the customer on (b)(4) 2012.A review of the repair history since (b)(6) 2013 indicates it has not been returned for preventive maintenance (pm), calibration or repair.The 2nd device, gs1002, serial (b)(4) was also supplied to the customer on (b)(4) 2012.It has not been returned for pm, calibration or repair during 2013 or 2014.The 3rd device, gs1002, serial (b)(4) was supplied on (b)(4) 2014.It was returned as an out-of-box failure.The analog & display boards were replaced.It has not been returned for pm, calibration or repair.The instruction manual (intended use) states: the gs1000 series of insufflators shall be used for gas distension of the abdomen for diagnostic and/or operative laparoscopy.They should be used only when laparoscopic procedures are called for, and should therefore not be used for any other treatments.They are designed to function with specific laparoscopic instruments that provide passage of gas to the intra-abdominal cavity and should only be used with instruments specifically designed for that purpose.They should only be used under the direct guidance of a skilled laparoscopic surgeon.Based on the intended use, evaluation results and all available information to date, there is no suggestion/evidence the gs1002 associated with this report was linked in any way to the cardiac event.Nonetheless, an investigation is still in progress and a final report will be submitted once additional testing and evaluations have been performed on all three units.

Manufacturer Narrative

The manufacturer has confirmed that all three (3) gs1002 have tested for proper operation and performed as expected.Additional testing was conducted as appropriate to the specific customer feedback for each unit (i.E.Overpressure functionality, overpressure alarms, pressure release valve functionality) and found to operate as intended.A review of the device complaint history shows there have been no similar events where a cardiac event has been reported.In addition, a 2-year review of the device complaint history showed there were no serious injuries or deaths related to the reported problem of "unable to regulate flow/pressure" or the use of this device.

• Brand Name: INSUFFLATOR 40L WARM READY
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 4370512
• MDR Text Key: 5118444
• Report Number: 1017294-2014-00063
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: GS1016 INSUFFLATOR TUBING SET, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 54