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 Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that foreign material was found inside the sterile package.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: debris in the packaging probable root cause: manufacturing/assembly/ service error incorrect or inadequate packaging severe shipping conditions user error the reported failure mode will be monitored for future reoccurrence.81.

Event Description

It was reported that foreign material was found inside the sterile package.

• 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
• MDR Report Key: 10529417
• MDR Text Key: 207751973
• Report Number: 0002936485-2020-00375
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 37613327061360
• UDI-Public: 37613327061360
• Combination Product (y/n): N
• PMA/PMN Number: K954726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 20028FG2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1