MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., STRYKEFLOW 2 WITH TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 0250070520

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that there was foreign material inside of the sterile packaging.

Manufacturer Narrative

Alleged failure: a hair was found inside of strykeflow 2 suction/irrigation packaging.Hair was identified by scrub tech/circulating nurse.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be foreign material fell inside during packaging.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 Description

It was reported that there was foreign material inside of the sterile packaging.

• Brand Name: PKG., ASSY., STRYKEFLOW 2 WITH TIP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6825577
• MDR Text Key: 83951698
• Report Number: 0002936485-2017-00819
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 0250070520
• Device Lot Number: 17152FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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