MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR¿; LAPAROSCOPIC INSUFFLATOR

Model Number FM300

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

The most probable root cause cannot be determined at present due to the insufficient information.As a malfunction of the device cannot be excluded, the event is considered reportable.

Event Description

We have been informed of the following event: "during the procedure with ref: (b)(4) sn: (b)(4) there was a cardiac arrest.According to medical personnel it was caused by the medical device.Vital functions have been restored.".

Event Description

We have been informed of the following event: "during the procedure with ref: (b)(4) sn: (b)(6) there was a cardiac arrest.According to medical personnel it was caused by the medical device.Vital functions have been restored.".

Manufacturer Narrative

Affected devices: pneumoclear fm300; serial number: (b)(6).The inital report was filed with fda on 7th july 2022.(mfr# 3002914049-2022-00005).In the meantime t the insufflator fm300 was returned and evaluated.Full functional testing was conducted, and the device was found to be working per specifications.

• Brand Name: PNEUMOCLEAR¿
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 14948587
• MDR Text Key: 295452301
• Report Number: 3002914049-2022-00005
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

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 Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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): Life Threatening
• Patient Age: 46 YR
• Patient Sex: Male