MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AISEAL INSUFFLATION UNIT

Catalog Number AS-IFS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The service history was reviewed and no data was found.A review of the dhr has been requested to the manufacturer but has yet to be received.(b)(4).Per the instructions for use, the user is advised the following: improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in gas embolism.To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.Check the position of the insufflation instrument immediately if the actual pressure rapidly reaches the nominal pressure value, gas embolisms can also be caused by a high intra-abdominal pressure.Avoid high-pressure settings and close damaged blood vessels at once.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed (b)(4) reported on behalf of their facility that the as-ifs1 airseal insufflator unit, was used in a laparoscopic liver resection on (b)(6) 2020.The surgery was started with the set abdominal pressure 10mmhg.Approximately 30-minutes into the procedure the pressure was bumped to 12mmhg.The vital signs of the patient decreased.Using the transesophageal echocardiography, bubbles were confirmed.At the request of the anesthesia team the laparoscopic surgery was converted to an open surgery.The surgery was completed in about 7 hours.According to the surgeon the surgery took 3 hours longer due to the conversion to open.Immediately after surgery a ct was done there was no confirmation of stroke, but the patient did report having discomfort in his left hand.Three (3) days after the surgery, another ct was performed, and a stroke was confirmed.The patient has no history or stroke or vascular issues, however, does have cirrhosis.The patient is under follow up observation and the discomfort in his left hand has gone away.There was no indication that the airseal malfunctioned or did not perform as intended.The risks of venous gas embolism or co2 embolism in minimally invasive liver resection is well-published for any type of laparoscopic liver surgery.This report is being raised as patient injury due to the conversion of a laparoscopic surgery to an open procedure.

• Brand Name: AISEAL INSUFFLATION UNIT
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin, 10587 ; GM 10587
• Manufacturer Contact: melanie lannon ; 11311 concept boulevard; largo, fl ; 3995209
• MDR Report Key: 10174563
• MDR Text Key: 201013239
• Report Number: 3006217371-2020-00255
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2020

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 Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 64 YR