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

Catalog Number 0620-040-680

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

Plastic tip on stryker co2 tubing broke off after opening it onto sterile field.All pieces found.Pieces broken off inside the package.Second tubing obtained.

• Brand Name: PNEUMOSURE INSUFFLATOR TUBING
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court; san jose CA 95138
• MDR Report Key: 4616393
• MDR Text Key: 15833082
• Report Number: 4616393
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/18/2015

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: Invalid Data
• Device Catalogue Number: 0620-040-680
• Device Lot Number: 56003475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO, EVENT HAPPENED PRIOR TO REACHING THE PATIENT.