MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER PNEUMOCLEAR HIGH FLOW TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Catalog Number REF 0620050100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/19/2019

Event Type  malfunction  

Event Description

Rn attempted to turn on the insufflation.The monitor was saying "invalid".She unplugged it, turned the machine off and back on and the same error popped up.She then changed the insufflation tubing and the error did not appear.Fda safety report id# (b)(4).

• Brand Name: STRYKER PNEUMOCLEAR HIGH FLOW TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY ; san jose CA 95138
• MDR Report Key: 9653771
• MDR Text Key: 177399307
• Report Number: MW5092665
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Catalogue Number: REF 0620050100
• Device Lot Number: 4016548
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 53 YR