MAUDE Adverse Event Report: STRYKER GLOBAL HEADQUARTERS INSUFFLATION TUBING

Model Number 0620-040-660

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2016

Event Type  Injury  

Event Description

Insufflation tubing would not connect properly to insufflator.Tubing replaced with one that worked properly.No harm to pt.Mfr: please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number below.

• Brand Name: INSUFFLATION TUBING
• Type of Device: INSUFFLATION TUBING
• Manufacturer (Section D): STRYKER GLOBAL HEADQUARTERS; 2825 airview blvd.; kalamazoo MI 49002
• MDR Report Key: 5832738
• MDR Text Key: 50856400
• Report Number: MW5063719
• Device Sequence Number: 1
• Product Code: NKC
• 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: 07/19/2016

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: 06/30/2019
• Device Model Number: 0620-040-660
• Device Lot Number: 16C0131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR