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 /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/10/2021

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 packaging.

Manufacturer Narrative

Alleged failure: there is a piece of black debris (potentially a bug) in the sterile packaging.There is also a sticky blue substance on the tubing the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the tyvek cover was dirty or the packagers hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that foreign material was found inside 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
• MDR Report Key: 12132189
• MDR Text Key: 262654793
• Report Number: 0002936485-2021-00361
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250070520
• Device Lot Number: 21102FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1