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

Catalog Number 0250070600

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 05/12/2015

Event Type  malfunction  

Event Description

It was reported that hair was found in the package during unpacking the device.

Manufacturer Narrative

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

Manufacturer Narrative

The reported failure mode of "foreign material" was confirmed on the unit returned for evaluation.As per risk documents most probable root causes for the following failure mode are: 1.Manufacturing/assembly error.2.User error in not properly inspecting unit prior to use.Based on the investigation results the root cause is deemed to be manufacturing/assembly error.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 hair was found in the package during unpacking the device.

• Brand Name: AHTO SUCTION/IRRIGATION TUBE SET (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: 4860869
• MDR Text Key: 5811363
• Report Number: 0002936485-2015-00523
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070600
• Device Lot Number: 14303FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• 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