MAUDE Adverse Event Report: STRYKER ENDOSCOPY PNEUMOCLEAR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620050200

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 03/09/2018

Event Type  malfunction  

Event Description

Error message.Invalid tubing.No further information available.

• Brand Name: PNEUMOCLEAR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 7550372
• MDR Text Key: 109443579
• Report Number: 7550372
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 0620050200
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1