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

Model Number 0620040690

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Event 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
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 7831992
• MDR Text Key: 118746182
• Report Number: 7831992
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327055658
• UDI-Public: (01)07613327055658(11)170217(17)200217(10)56005269
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620040690
• Device Catalogue Number: 0620-040-690
• Device Lot Number: 56005269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Weight: 65