MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX); SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 0250070620

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

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

It was reported that white residue was found on the probe of the product.The white residue was noticed at the beginning of the case when they were opening the packaging.

Manufacturer Narrative

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

Manufacturer Narrative

The particle/debris condition was not confirmed since the unit was not received.As per risk document likely root causes are: 1.Manufacturing/assembly error; 2.Incorrect or inadequate packaging; 3.Severe shipping conditions.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that white residue was found on the probe of the product.The white residue was noticed at the beginning of the case when they were opening the packaging.

• Brand Name: AHTO SUCTION/IRRIGATION TUBE SET 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: 4910687
• MDR Text Key: 21545868
• Report Number: 0002936485-2015-00629
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070620
• Device Lot Number: 14302FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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