MAUDE Adverse Event Report: STRYKER ENDOSCOPY PNEUMO SURE HIGH FLOW INSUFFLATOR; INSUFFLATOR LAPAROSCOPIC

Lot Number 18G0269

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Date 01/25/2019

Event Type  malfunction  

Event Description

While using the co2 insufflator tubing during a robotic-assisted surgery, staff noticed a leak.

• Brand Name: PNEUMO SURE HIGH FLOW INSUFFLATOR
• Type of Device: INSUFFLATOR LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; san jose CA 95138
• MDR Report Key: 8286234
• MDR Text Key: 134571130
• Report Number: MW5083428
• 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: 01/25/2019

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 Expiration Date: 07/01/2021
• Device Lot Number: 18G0269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 59