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

Catalog Number 0250070500

Device Problem 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 the items caused a ridge in the packaging.

Manufacturer Narrative

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

Event Description

It was reported that the items caused a ridge in the packaging.

Manufacturer Narrative

The failure mode of damaged/broken tyvek was confirmed on the received unit.Root cause was determined by visual inspection, usage experience and risk document analysis to be most likely caused by: incorrect or inadequate packaging, severe shipping conditions and improper storage.None could be ruled out so root cause will remain as multi factorial.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: 3747079
• MDR Text Key: 15360228
• Report Number: 0002936485-2014-00211
• 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: 13309FG2
• 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