MAUDE Adverse Event Report: STRYKER PUERTO RICO, LLC. PNUMOCLEAR INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Device Problems Inflation Problem (1310); Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Inflation pump failed requiring conversion to open for repair of right inguinal hernia.At approximately 0930 on (b)(6) 2022 a patient in operating room 2 was undergoing laparoscopic bilateral hernia repair procedure, when the co2 insufflation machine completely powered off.Fda safety report id# (b)(4).

• Brand Name: PNUMOCLEAR INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER PUERTO RICO, LLC.
• MDR Report Key: 15720403
• MDR Text Key: 303059166
• Report Number: MW5113054
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: FM300
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic