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 Pressure Problem (3012)

Patient Problem Laceration(s) (1946)

Event Date 06/28/2023

Event Type  Injury  

Event Description

We have been informed of the following event: " pneumoclear gas pressure low msg with new gas tanks.Re-ported by biomed (b)(6), during a case, while the case was still going on.Have the setup with two tanks.Both tanks are new before the case.Continued to provide gas through the surgery.No delay to the surgery - when reported the case was still going on.Did say the 2 year maintenance sticker says should be due june 2023.Customer may have received that message also.Additional information from wom employee (b)(4).On 2023-07-13 ".Device identification => the returned device was confirmed to be a pneumoclear insufflator sn: (b)(6) rma: 3024258.Interim evaluation results at wom side no negative trend visible.Review of the dhr revealed no discrepancies.The information obtained does not indicate that the device has caused or is likely to cause death, serious injury or malfunction in a manner that would be likely to cause or contribute to death or serious injury if repeated.Additional information from stryker employee (b)(4).On 2023-08-15 "hello all, i'm sorry it appears the additional information was not shared with wom.The original notification form does not include any additional information at the time the notification was sent.I've attached an updated notification form for your reference as well as additional information that we received from our rep below: at the time of cancelation, was the patient only under anesthe-sia, or had incisions already been made? initial incision had been made.1.Was the procedure completed successfully? no, had to can-cel the case.This is the only insufflator they had available at the time.2.Is the product coming back for evaluation? yes, it will be sent back.3.If a patient was involved in this event, can you please provide any of the following patient information: 1.Patient code (not name) na.2.Age at time of the event or dob.3.Gender: female.4.Weight.Thank you, (b)(4)" additional information from wom employee (b)(4).On 2023-08-21 because of new information, the complaint was reopened and rated c.Problem description - update after reopening the complaint event date: (b)(6) 2023.Initial reporter name: (b)(6).Initial reporter facility: (b)(6).Phone number: (b)(6).Email: na.How was issue noticed?: during.Procedure completed successfully?: no.Patient involvement?: yes - no impact.Medical intervention?: no.Surgical delay?: no.Adverse consequences?: no.Adverse consequence details: the case had to be cancelled and the patient already had the initial incision at the time of can-celation.Product available for return?: return.Detailed description - update after reopening the complaint event description/alleged problem(s): pneumoclear gas pres-sure low msg with new gas tanks.Reported by biomed (b)(6), during a case, while the case was still going on.Have the setup with two tanks.Both tanks are new before the case.Continued to provide gas through the surgery.No delay to the surgery - when reported the case was still going on.Did say the 2 year maintenance sticker says should be due june 2023.Customer may have received that message also.Salesforce case number (b)(4) update: the case had to be cancelled and the patient already had the initial incision at the time of can-celation.".

Manufacturer Narrative

The device was returned for evaluation.The results of the functional inspection were as follows: initial self-check passed, no errors occurred, service due warning message on display, no errors logged, and full functional testing performed passing all.The complaint was not confirmed.Cosmetic repairs and preventive maintenance were carried out on the device.The device has been calibrated and a software update has been performed.No further action is indicated at this time.Therefore, the most possible root cause might be a user error.An incision has already been made in the patient, but patient harm has not been reported.Since no replacement device was available, the operation was aborted.

• 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: 17742982
• MDR Text Key: 323476208
• Report Number: 3002914049-2023-00010
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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
• Date Returned to Manufacturer: 07/12/2023
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female