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

Model Number FM300

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

The accumulation of gas in the scrotum, labium or the penis are very rare but can happen due to a tissue defect between the abdomen or the inguinal (leisten) and the genitals.In this case, having the device set at 15 mmhg for an inguinal hernia seems too high and might increase the risk for side effects.So it seems to be an issue caused by the settings of the user not being appropriate for the patient.However, the doctor does not believe the insufflator is at fault and to support this the device was evaluated by the manufacturer and found to be functioning as per specification.Nonetheless, the event description includes a defined risk to patient's health and led to patient injury requiring medical intervention.If the injury was permanent or temporary could not be determined due to availability of limited information at the time of reporting decision.

Event Description

We have been informed of the following event: "the complaint was that the insufflator was not reading pressure correctly during and caused the patient's penis to increase in size (insufflate).The issue was not recognized until after the procedure was completed.How was issue noticed?: during procedure completed successfully?: yes.Patient involvement?: yes - impact.Medical intervention?: no.Surgical delay?: no.Adverse consequences?: no.Adverse consequence details: no delays, caused the patient's penis to increase in size (insufflate).Update: the patient's penis increased in size up to 4x and split open.Product available for return?: return.Additional information from stryker employee on 10/23/2023.Also here is additional information logged for this complaint: "call with rep states that the penis increased in size 4 times and split open requiring stitches to close it.Doctor does not believe the insufflator is at fault but wanted to use a different insufflator at the time.Wants this insufflator sent back for inves-tigation.Event occured 6 weeks ago." device identification => the returned device was confirmed to be a pneumoclear insufflator s/n (b)(6).Rma 3025105" additional information from stryker employee on 11/02/2023.Q4: type of procedure? a4: bilateral laparoscopic inguinal hernia.Q6: age and bmi of patient? a6: male.Q8: chosen settings for abdominal pressure in mmhg? a8: defaults at 15 for this account.Q12: was this device used successfully in any other surgeries prior to this procedure? a12: no problems prior.Only after this case was it removed from surgery".

• 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 poststra?e 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: 18100098
• MDR Text Key: 327713950
• Report Number: 3002914049-2023-00012
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FM300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male