MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AIRSEAL IFS, 230V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS2

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

The customer reported that the as-ifs2, airseal ifs, 230v device was being used during an arthroscopic hemicolectomy procedure on (b)(6) 2021 when it was reported that ¿heavy intraoperative bleeding and impoible to increase intra abdominal pessure.The surgeon finished the surgery without being able to increase the pressure.Impossible to stop the surgery and change the insufflator.¿ after further assessment, it was found that when the airseal control screen got stuck, the problem encountered was that it was not possible to increase the pressure until the end of the operation when the surgeon was facing more severe bleeding from the patient.The bleeding was finally controlled by the surgeon.He did not have to convert to a laparotomy.There was no injury to the patient, just management of the risk of bleeding made more difficult.It is not known if there was a delay.There was no report of impact or injury to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Additional fda product code: gcj reported event is inconclusive.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 device history review was requested from the supplier but has yet to be received.(b)(4).Per the instructions for use, the user is advised the following: use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established; ensure that the patient is properly positioned so that organs are away from the penetration site; direct the airseal access port¿s tip away from significant vessels and organs; do not use excessive downward force and once a safe and proper entry has been achieved, ensure that the black line at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the as-ifs2, airseal ifs, 230v device was being used during an arthroscopic hemicolectomy procedure on (b)(6) 2021 when it was reported that ¿heavy intraoperative bleeding and impossible to increase intra abdominal pressure.The surgeon finished the surgery without being able to increase the pressure.Impossible to stop the surgery and change the insufflator.¿ after further assessment, it was found that when the airseal control screen got stuck, the problem encountered was that it was not possible to increase the pressure until the end of the operation when the surgeon was facing more severe bleeding from the patient.The bleeding was finally controlled by the surgeon.He did not have to convert to a laparotomy.There was no injury to the patient, just management of the risk of bleeding made more difficult.It is not known if there was a delay.There was no report of impact or injury to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL IFS, 230V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin NY 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin NY 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12722237
• MDR Text Key: 281335740
• Report Number: 1320894-2021-00394
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/22/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic