MAUDE Adverse Event Report: W.O.M WORLD OF MEDICINE GMBH AIRSEAL IFS, 110V; INSUFFLATOR, LAPAROSCOPIC

Catalog Number AS-IFS1

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

Patient Problem Infiltration into Tissue (1931)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Additional product code; gcj.Investigation of the customer's reported issue and complaint was inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, the reported failure cannot be verified, and root cause can not be identified.As a serial number was not provided, conmed could not conduct a review of the service history or review the manufacturing documents from the device history record (dhr) reports.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.During this same time frame 1864 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.004, however, because this is a reusable device, the potential number of uses is not considered in this occurrence rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed product tech support received a call from (b)(6) medical center regarding issues with the as-ifs1, airseal ifs unit, serial number unknown that occurred on (b)(6)2021.The product tech support contacted the conmed sales representative who visited the medical center to follow up.It was reported that patient had issue with sub q.The facility reports the issue had nothing to do with the conmed device/machine.The reporter, or charge nurse (b)(6), was adamant that the conmed airseal was not the concern, it had nothing to do with the airseal and the doctor did not want to discuss it further.The procedure was a diagnostic laparoscopic gyn procedure which was successfully completed.It is unknown if the sub q occurred during or after procedure.Facility wants no follow up and no further discussion.Patient was (b)(6)yrs old, female, (b)(6)kg in weight, her current condition is reported to be "fine" with no impact/injury.Although requested, no other information or incident details were made available by the facility and they want no further contact.Although there is no allegation of defect or fault with the airseal unit, this mdr reporting is being raised on the basis of injury for the mention of sub q.

• Brand Name: AIRSEAL IFS, 110V
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• 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: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 11649554
• MDR Text Key: 245925645
• Report Number: 1320894-2021-00170
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/12/2021
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 89