MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) INSUFFLATOR HEAT FR 45L/MIN

Model Number 2235021

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

Richard wolf (b)(4) received actual device from user facility on 11/28/2016.Investigation/evaluation currently in process.Request for missing information (ie patient information) sent to facility, no response as of 12/13/2016.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).Evaluation currently in process.

Event Description

Richard wolf (b)(4) was notified that at the beginning of a laparoscopic right colectomy the self test of the device in question displayed an error.There was no back up device available so doctor went to an alternative method, an open surgery.No negative consequences for the patient reported.

Manufacturer Narrative

Follow up #1.The following sections updated/added: product problem, suspect device, all manufacturers, device manufacturers.The 2235021 insufflator 45 heat fr 45l / min with sn (b)(4) has been tested by the appropriate department and the error message: 452-150-420 '"pneumatic component malfunction 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 27mar2014.The production batch 1240832 consists of a total of (b)(4) insufflators.To the customer, the 2235021 insufflator 45 heat fr 45l / min was delivered on (b)(6) 2014 with the sn (b)(4) under the order number (b)(4).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 (b)(4) / 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 can not generally be ruled out.For therapeutic use, therefore, an equivalent replacement must be available because of possible failures.The user did not act in accordance with this instruction, so he had to switch to the conservative procedure because no equivalent device was available.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 medical instruments corporation (rwmic) submitting report on behalf of (b)(4).

Event Description

Follow up #1.

• Brand Name: INSUFFLATOR HEAT FR 45L/MIN
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; FK 75438
• Manufacturer (Section G): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 6177552
• MDR Text Key: 62866136
• Report Number: 9611102-2016-00017
• 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: 11/17/2016

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: Physician
• Device Model Number: 2235021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: 11/17/2016
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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