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

Catalog Number 0250070520

Device Problem Device Packaging Compromised (2916)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

It was reported that there was a hair inside the sterile pack.

Manufacturer Narrative

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

Manufacturer Narrative

The foreign material failure mode was confirmed on the unit returned.A small strand of hair was found inside the blister package.Most probable root causes are: manufacturing/assembly error, incorrect or inadequate packaging.As per the evidence at hand root cause is a manufacturing error.This was deduced due to current risk documents and investigation.As per current risk documents, the event is within predicted acceptable occurrence and severity thresholds.The risk is within the green low acceptable level.There are mitigating procedures in place.No further actions are deemed necessary at this time the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a hair inside the sterile pack.

• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4664652
• MDR Text Key: 5608332
• Report Number: 0002936485-2015-00278
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070520
• Device Lot Number: 14288FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2015
• 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