MAUDE Adverse Event Report: RICHARD WOLF GMBH HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN

Model Number 2235.031

Device Problems Failure to Auto Stop (2938); Infusion or Flow Problem (2964)

Patient Problem Abdominal Distention (2601)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

A questionnaire was sent to the customer.It was confirmed that the problem was detected during use, and that there was no patient harm (no death, no serious injury).It was also confirmed that there was a significant delay of 15 minutes caused by the issue, but the procedure was completed successfully.There was no change in the condition of the patient caused by use of the device, as the malfunction was noticed at an early stage of the procedure.Note: this device reported here with the product type number 2235.031 is not sold in usa.However, an equivalent device is marketed in the usa.The device is available for evaluation, the return of the device has been requested, but the device has not yet been returned to richard wolf (b)(4).Investigation of the device will be carried out when the device is received, and a follow up report will be submitted with the investigation results.

Event Description

On (b)(6) 2019, richard wolf (b)(4) (rw(b)(4)) was notified of the following event: during a procedure on (b)(6) 2019, insufflation was started as usual after completing mini laparotomy.The insufflation did not stop automatically.At the time, the problem was detected, over 10 liters were already insufflated with correspondingly high unregulated abdominal pressure.

Manufacturer Narrative

The device was returned to richard wolf gmbh for investigation.The insufflator has several protective (safeguard) functions that are based on software and hardware solutions.Device errors that occur are stored in the log file within the device.For the insufflator, the log file was read out and analyzed, a functional test in accordance with the test plan and a nine-hour continuous test were carried out.In all of the tests conducted, the defect described by the user did not occur and was not registered as an error by the integrated device monitoring system or recorded in the error memory.Normal, correct use was simulated on the customer's insufflator 2235031 sn1100284622 and the error described by the user could not be reproduced.No errors are stored in the device memory (logfile) that may be related to the reported incident.Regarding the uncontrolled filling quantity of 10 liters described by the user, the concept of the device's safeguards was scrutinized.During use, about 25 liter/min flows through the hose (3mmluer).However, the reduction by the trocar and the optics also need to be considered, and this leads to a further reduction, so it can be assumed that a realistic flow rate is about 20liters/min.This would mean that the device would have insufflated for about 30seconds.The hardware monitoring system is activated as early as 1.6seconds.In the case of a pneumatic defect, a pressure greater than 45mmhg would trigger the hardware monitoring system.This would generate the error 401:> 45mmhg 5sec.Which would be stored in the logfile when it occurs.In summary, no functional defects in the device or deficiencies in the safeguard concept were found.In the instructions for use ga-a274, it is pointed out that an equivalent replacement device must be available for therapeutic use in case of possible failures.In addition, in chapter 1.4, contraindications and side effects are described, which should be considered together with chapter 1.5 where possible combinations are described.The exact circumstances that led to the incident as described by the user cannot be clarified.Based on the investigation, no further measures or actions will be initiated by the manufacturer.The following fields contain new/changed information: d10, g4, g5, g7, h2, h3, h6, and h10.

• Brand Name: HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN
• Type of Device: HIGHFLOW INSUFFLATOR 45 EVAC + HEAT FR 45L/MIN
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8822641
• MDR Text Key: 204415803
• Report Number: 9611102-2019-00006
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K991906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2235.031
• Device Catalogue Number: 2235.031
• Device Lot Number: 1100284622
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other