MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE STRYKEFLOW2 WITH DISPOSABLE TIP (6BX); SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 0250070520

Device Problems Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was reported that upon opening the packaging the tubing was dirty and a white powdery residue was seen on the irrigation tip.

Manufacturer Narrative

The foreign material failure mode was confirmed on the product received.Likely root causes are: manufacturing/assembly error, incorrect or inadequate packaging, severe shipping conditions, user error in not properly inspecting unit prior to use, as per risk documents.We concluded the most probable root causes to be: severe shipping conditions due to visual inspection, investigation findings and risk documents.In sum.The unit was returned and the failure mode was confirmed.

Event Description

It was reported that upon opening the packaging the tubing was dirty and a white powdery residue was seen on the irrigation tip.

Manufacturer Narrative

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

• Brand Name: STRYKEFLOW2 WITH DISPOSABLE 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: 3933557
• MDR Text Key: 4771487
• Report Number: 0002936485-2014-00501
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070520
• Device Lot Number: 14132FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2014
• 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