MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 0250070484

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/30/2014

Event Type  malfunction  

Event Description

It was reported that a black smudge came off of the tip of the device onto the surgeons hand.

Manufacturer Narrative

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

Event Description

It was reported that a black smudge came off of the tip of the device onto the surgeons hand.

Manufacturer Narrative

The failure mode "black smudge coming from tip" was confirmed.Probable root causes that may be associated, but are not limited to: manufacturing assembly error; incorrect or inadequate packaging; severe shipping conditions; improper cleaning/sterilization leading to rust/corrosion.From the investigation and evidence gathered it was determined that root cause was user error not following the instruction for use in the sense that the device was improperly cleaned.There were no delays, no additional medical intervention and no adverse effects reported in this event.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.       .

• Brand Name: 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH
• 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: 3839652
• MDR Text Key: 4680686
• Report Number: 0002936485-2014-00366
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250070484
• Device Lot Number: 10039742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• 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