MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX); APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0250070620
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Alleged failure: white residue.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be extreme shipping conditions.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).
Event or Problem Description
It was reported that white residue was found on the probe of the product.

• Brand Name: AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX)
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 5786623
• Report Number: 0002936485-2016-00675
• Device Sequence Number: 491833
• Product Code: GCX
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K042454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 0250070620
• Device Lot Number: 14302FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Initial Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1