MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CHIBA 22G, 14.9CM; DEVICE, PERCUTANEOUS, BIOPSY

Catalog Number 0921225000

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

The reported device was discarded by the customer and not received for evaluation.

Event Description

It was reported the tip fractured off the device during a procedure at the healthcare facility.The tip was removed and the procedure was completed successfully.It was also reported there was no impact on the patient and no adverse consequences.

• Brand Name: CHIBA 22G, 14.9CM
• Type of Device: DEVICE, PERCUTANEOUS, BIOPSY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5828276
• MDR Text Key: 51235637
• Report Number: 0001811755-2016-01315
• Device Sequence Number: 1
• Product Code: MJG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0921225000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1