MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) INSUFFLATOR

Model Number 2235021

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Actual device returned to manufacturer on 12/02/2016.Investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).Device currently being evaluated.

Event Description

In the middle of a cholecystectomy operation the device stopped working and display error appeared.User changed out the unit and procedure could be completed with backup insufflator.No negative consequences for the patient.

Manufacturer Narrative

Follow up.The following sections updated/added: product problem,- suspect device, all manufacturers, device manufacturers.The 2235021 insufflator 45 heat fr 45l / min with the sn (b)(4) has been checked by the responsible specialist department and the error message: 452-150-420 '"pneumatic component fault has been detected".The pressure sensor of the function board 64352356 is defective.The electronic pressure sensor of the insufflator gives a wrong voltage value off.This error is detected after the device is switched on during the self-test and displayed as an error message in the display.Due to the error description of the customer is to assume a sporadic mistake.The 2235021 insufflator 45 heat fr 45l / min with sn (b)(4) was produced on 21jun2013.The production batch 1212128 consists of a total of 24 insufflators.To the customer, the 2235021 insufflator 45 heat fr 45l / min was delivered on (b)(6) 2013 with the sn (b)(4) as job order number (b)(4).In the last repair (b)(6) on (b)(6) 2014, the heating module was replaced.The user is informed of the possibility of a device defect in the instructions for use of the insufflator highflow 45 2235 ga-a 274 / de / 2016-04 v5.0 / pdg 15-8210.In order to detect errors early, the measures described in chapter 3 "commissioning" and chapter 4 "checks" must be observed and carried out before starting the laparoscopy.Despite various protection and control functions integrated in the device concept, a device error cannot generally be ruled out.For therapeutic use, therefore, an equivalent replacement must be available because of possible failures.The user acted in accordance with this instruction.When he noticed the failure, he decided to use alternative equipment and finished the operation with it.Potential hazards were taken into account in the risk assessment e1-1 r05 with the corresponding extent of damage and probability of occurrence and assessed with an acceptable risk.This rating is still valid considering the current case.Richard wolf (b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf (b)(6) submitting report on behalf of (b)(4).

Event Description

Follow up.

• Brand Name: INSUFFLATOR
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 6224052
• MDR Text Key: 63917997
• Report Number: 9611102-2016-00019
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2235021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2013
• 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 Age: 70 YR