MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITHOUT TIP (6BX); SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 0250070500

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

It was reported that there was a foreign body, possible a hair, found while opening the sterile packaging.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was a foreign body, possibly a hair, found while opening the sterile packaging.

Manufacturer Narrative

The foreign material condition was confirmed on the product received.The device was visually inspected.A hair was found to have been sent within the unit.The most probable root causes could be: manufacturing/assembly error.This was determined as a result of analysis of visual inspection, investigation findings and risk documents.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

• Brand Name: STRYKEFLOW2 WITHOUT TIP (6BX)
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3747115
• MDR Text Key: 19022722
• Report Number: 0002936485-2014-00210
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070500
• Device Lot Number: 13297FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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