MAUDE Adverse Event Report: STRYKER CORPORATION PNEUMOSURE; INSUFFLATOR, LAPAROSCOPIC

Model Number	0620040690
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient scheduled for laparoscopic cholecystectomy.When it was time for the abdomen to be insufflated with carbon dioxide, the team noted that the abdomen was not insufflated.When they checked, the tubing covering the wires was not in its place.They appear to be separated from the grey colored plastic disc.The device was changed and adequate pneumoperitoneum was obtained.Lap cholecystectomy proceeded without any more untoward event.Patient tolerated procedure well with no complications.Manufacturer response for insufflator, laparoscopic, pneumosure (per site reporter).Surgery inventory coordinator to call company and report device.

• Brand Name: PNEUMOSURE
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 7831992
• Report Number: 7831992
• Device Sequence Number: 19327991
• Product Code: HIF
• UDI-Device Identifier: 07613327055658
• UDI-Public: (01)07613327055658(11)170217(17)200217(10)56005269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2018
• Report Date (Section F): 08/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: 0620040690
• Device Catalogue Number: 0620-040-690
• Device Lot Number: 56005269
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65
• Date Report Sent to FDA: 08/22/2018