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

Catalog Number 0250070500

Device Problem Device Packaging Compromised (2916)

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

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that there was a small bug/insect inside the blister package.

Event Description

It was reported that there was a small bug/insect inside the blister package.

Manufacturer Narrative

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

Manufacturer Narrative

The foreign material failure mode was confirmed on the returned unit.A fly wing was returned with the blister of the device.The wing was determined to be of a species endemic to subtropical areas.Physical examination of the returned product and additional testing by our team concluded that possible root causes could be attributed to: manufacturing/assembly error, severe shipping conditions, incorrect or inadequate packaging and user error in not properly inspecting unit prior to use.We concluded that the most likely root cause is manufacturing/assembly error due to event description and investigation findings.In sum, the product was returned and the failure mode was confirmed.

• 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: 3614147
• MDR Text Key: 4170526
• Report Number: 0002936485-2014-00062
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070500
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2014
• 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