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

Model Number	FM300
Medical Device Problem Codes	Off-Label Use (1494); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
We have been informed of the following event: "pediatric case pneumoclear plus co2 conditioning insufflator (americas) was over pressured with patient.Patient vitals went down when insufflation stopped.The patient's vitals went back to normal.(.) we were using a 5mm scope with a size 5mm trocar (onb5shf).The insufflator box didn't give off any warning signals or sounds, we were only aware because of the patients' status changing.".How was issue noticed?: during.Procedure completed successfully?: no.Patient involvement?: yes - impact.Medical intervention?: no.Surgical delay?: yes - 20 min.Adverse consequences?: patient and user.Adverse consequence details: 20 minute delay to swap out towers with new pneumoclear plus co2 conditioning insufflator.Product available for return?: return.
Additional Manufacturer Narrative
A possible serious injury was reported that required medical or surgical intervention to preclude perma-nent impairment of a body function.The investigations of the device confirmed that the device is work-ing according to the specifications.The complainant stated that during a pediatric surgery, the patient´s vitals went down and when insufflation stopped patient´s vitals went back to normal.It was stated that the user used the advanced mode and not the pediatric mode as intended.The pediatric operating mode is designed for these patient groups.Therefore, the most probable root cause is an off-label use and/ or an user error and is considered reportable.

• Brand Name: PNEUMOCLEAR¿
• Common Device Name: 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 poststra[?]e 11; ludwigsstadt 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 16864925
• Report Number: 3002914049-2023-00002
• Device Sequence Number: 5478575
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown