MAUDE Adverse Event Report: STRYKER PNEUMOSURE INSUFFLATION TUBING; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620-040-690

Device Problems Break (1069); Product Quality Problem (1506); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 01/08/2016

Event Type  Injury  

Event Description

Opened sterile insufflation tubing to surgical field and found the item to be broken.

• Brand Name: PNEUMOSURE INSUFFLATION TUBING
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER; 5900 optical court; san jose, CA 95138
• MDR Report Key: 5488916
• MDR Text Key: 39976967
• Report Number: 5488916
• 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: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 0620-040-690
• Device Lot Number: 15G0272
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 79