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 Shipping Damage or Problem (1570); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was foreign material in sterile packaging.

Event Description

It was reported that there was foreign material in sterile packaging.

Manufacturer Narrative

The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: foreign material found inside the sterile packaging probable root cause: manufacturing/assembly/service error; incorrect or inadequate packaging; severe shipping conditions; user error.H3 other text: 81.

• 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: 11968700
• MDR Text Key: 258925851
• Report Number: 0002936485-2021-00305
• 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: 07/29/2021

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: Other
• Device Catalogue Number: 0250070520
• Device Lot Number: 21024FG2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1