AIRSEAL
Report
- Report Number
- 1320894-2025-00154
- Event Type
- Injury
- Date Received
- June 12, 2025
- Date of Event
- May 27, 2025
- Report Date
- July 15, 2025
- Manufacturer
- W.O.M. WORLD OF MEDICINE GMBH
- Product Code
- HIF
- UDI-DI
- 10851885004587
- PMA / PMN Number
- K190303
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
AN EVALUATION OF THE RETURNED DEVICE COULD NOT DUPLICATE THE REPORTED EVENT. A FUNCTIONALITY TEST OF THE UNIT PASSED ON EVERY STEP. THE UNIT RAN IN DIFFERENT MODES FOR APPROXIMATELY TWO HOURS, AND NO PROBLEMS WERE DETECTED. ADDITIONALLY, THE UNIT PASSED THE TWELVE-HOUR TEST. THE UNIT WAS TESTED PER IP-800-031 AND FUNCTIONS PER THE SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUESTED FROM THE MANUFACTURER, AND NO INDICATION OF ABNORMALITIES WAS COMMUNICATED. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF SEVEN REPORTS, REGARDING SEVEN DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 0.000003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT INTRATHORACIC PRESSURES GREATER THAN 15 MMHG MAY INCREASE THE RISK OF CARDIOVASCULAR COLLAPSE. ENSURE FULL DEFLATION OF THE PASSIVE LUNG AT INITIAL INSUFFLATION. MAINTAIN INTRATHORACIC PRESSURE AT 5 ¿ 10 MMHG USING THE LOWEST PRESSURE POSSIBLE TO ALLOW FOR ADEQUATE VISIBILITY. INSUFFLATE AT 1 ¿ 3 LPM. IT IS ALSO ADVISED THAT THE INSUFFLATION OF CO2 SHOULD BE DONE CAREFULLY AND WHILE MONITORING THE PATIENT¿S RESPONSE. THE USER, PARTICULARLY THE ANESTHETIST, SHOULD BE INFORMED ABOUT POSSIBLE CARDIOVASCULAR AND RESPIRATORY PROBLEMS OF THE PATIENT AND MONITOR THESE INTRA-OPERATIVELY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
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. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
A CUSTOMER REPORTED THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED ON (B)(6) 2025, AND ¿DURING A RAL RIGHT PARTIAL NEPHRECTOMY, THE AIRSEAL MACHINE DEPRESSURIZED AND FLOW READ AS 7 WHILE THE PERITONEAL PRESSURE READ AS ZERO. SURGEON REQUESTED THE MACHINE BE CHECKED JUST IN CASE IT WAS ACTING UP. A BACK UP MACHINE WAS BROUGHT IN THE ROOM AND STARTED UP BUT THE AIRSEAL CORRECTED ITSELF AND PRESSURE CAME UP TO 20.¿. THE REPORT ALSO STATES: ¿INJURY INCURRED? = NO. IMMEDIATE ACTIONS REPORTED: EQUIPMENT/DEVICE REMOVED FROM SERVICE/PATIENT MONITORED/ASSESSED. PATIENT IMPACT: PROCEDURE INTERRUPTED/RESUMED ON ANOTHER SYSTEM.¿. HOWEVER, THE REPORT ALSO STATED, "I WAS ALSO TOLD THE PATIENT EXPERIENCED PNEUMOTHORAX.". PER FURTHER ASSESSMENT, IT IS UNKNOWN WHEN THE PNEUMOTHORAX WAS DISCOVERED, BUT IT WAS INDICATED TO BE RELATED TO THE USE OR MALFUNCTION OF THE DEVICE. A "CHEST TUBE WAS PLACED IN PATIENT", AND BY (B)(6) 2025 "CHEST TUBE WAS REMOVED AND PATIENT WAS FINE". PNEUMOPERITONEUM WAS LOST DURING THE PROCEDURE, BUT IT IS UNKNOWN IF THE LOSS WAS GRADUAL OR SUDDEN. THE PROCEDURE WAS COMPLETED AS NORMAL WITH A "SLIGHT DELAY" DUE TO "AN INTERRUPTION IN THE PROCEDURE". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE.
A CUSTOMER REPORTED THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED ON (B)(6) 2025, AND ¿DURING A RAL RIGHT PARTIAL NEPHRECTOMY, THE AIRSEAL MACHINE DEPRESSURIZED AND FLOW READ AS 7 WHILE THE PERITONEAL PRESSURE READ AS ZERO. SURGEON REQUESTED THE MACHINE BE CHECKED JUST IN CASE IT WAS ACTING UP. A BACK UP MACHINE WAS BROUGHT IN THE ROOM AND STARTED UP BUT THE AIRSEAL CORRECTED ITSELF AND PRESSURE CAME UP TO 20.¿. THE REPORT ALSO STATES: ¿INJURY INCURRED? = NO. IMMEDIATE ACTIONS REPORTED: EQUIPMENT/DEVICE REMOVED FROM SERVICE/PATIENT MONITORED/ASSESSED. PATIENT IMPACT: PROCEDURE INTERRUPTED/RESUMED ON ANOTHER SYSTEM.¿. HOWEVER, THE REPORT ALSO STATED "I WAS ALSO TOLD THE PATIENT EXPERIENCED PNEUMOTHORAX.". PER FURTHER ASSESSMENT, IT IS UNKNOWN WHEN THE PNEUMOTHORAX WAS DISCOVERED, BUT IT WAS INDICATED TO BE RELATED TO THE USE OR MALFUNCTION OF THE DEVICE. A "CHEST TUBE WAS PLACED IN PATIENT", AND BY (B)(6) 2025 "CHEST TUBE WAS REMOVED AND PATIENT WAS FINE". PNEUMOPERITONEUM WAS LOST DURING THE PROCEDURE, BUT IT IS UNKNOWN IF THE LOSS WAS GRADUAL OR SUDDEN. THE PROCEDURE WAS COMPLETED AS NORMAL WITH A "SLIGHT DELAY" DUE TO "AN INTERRUPTION IN THE PROCEDURE". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1780121 | AIRSEAL | INSUFFLATOR, LAPAROSCOPIC | HIF | W.O.M. WORLD OF MEDICINE GMBH | 10851885004587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |