MAUDE Adverse Event Report: STRYKER ENDOSCOPY PNEUMO SURE XL HI-FLOW INSUFFLATOR; HI FLOW INSUFFLATOR

Model Number 620-040-610

Device Problem Defective Device (2588)

Patient Problems Death (1802); Hernia (2240); Complaint, Ill-Defined (2331); Loss Of Pulse (2562)

Event Date 05/08/2014

Event Type  Death  

Event Description

Pt admitted for laparoscopic hiatal hernia repair, nissen and lap cholecystectomy.Anesthesia induction done without incident.Abdomen was insufflated with co2 at 0731.At 0733, pt was pulseless, no o2 sat, etco2 =15.Pt in pea with thready carotic pulse <30 sec.Chest compressions started and acls protocol initiated.Abdomen opened and explored with no bleeding noted.Pt transferred to (b)(6) by paramedics.Pt expired in ed.Case reported to medical examiner-family refused autopsy.Biomed called to evaluate stryker insufflator (b)(6) 2014.Biomed reported that insufflator was defective.Co2 setting was set at 151min however, actual pressure at 38mmhg and going as high as 51mmhg.

• Brand Name: PNEUMO SURE XL HI-FLOW INSUFFLATOR
• Type of Device: HI FLOW INSUFFLATOR
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 3840226
• MDR Text Key: 4411926
• Report Number: MW5036346
• Device Sequence Number: 1
• Product Code: HIF
• 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: 05/21/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 620-040-610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Weight: 87