MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR; CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING

Model Number ST299

Device Problem Accessory Incompatible (1004)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

At the time of the reporting decision, neither the tube sets nor the device used during this event have been returned for evaluation and the evaluation results were not available.However, we investigated the retention samples from the same lot and the samples correspond to the specification they could be inserted into the insufflator and recognized without any problems.Accordingly, since the tube set from a different lot worked without any issue we cannot exclude a malfunction of the used tube sets for this procedure.Nonetheless, the event description includes a defined risk to patient's health and led conversion to open surgery (open procedure).

Event Description

We have been informed of the following event "they had 3 pneumoclear insufflator tubes not be recognized by the insufflator, it appears to be a problem with the tubing as tubing from a different box was working.The lot number was 4030185.To confirm there was only 1 insufflator and 3 tubesets involved in 1 case resulting in an open surgery.Event date: 01/25/2024.How was issue noticed?: during case.Procedure completed successfully?: yes.Patient involvement?: yes - no impact.Medical intervention?: yes.Surgical delay?: yes - 60 min.Adverse consequences?: patient.Adverse consequence details: open surgery rather than lapa-roscopic.Product available for return?: no - disposed of by customer.

• Brand Name: PNEUMOCLEAR
• Type of Device: CARBON DIOXIDE INSUFFLATOR FOR LAPAROSCOPY AND VESSEL HARVESTING
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 18815427
• MDR Text Key: 336625954
• Report Number: 3002914049-2024-00001
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

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: ST299
• Device Catalogue Number: 0620050250
• Device Lot Number: 4030185
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other