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 Sparking (2595); Insufficient Information (3190)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a thermal event.

Manufacturer Narrative

Alleged failure: midway through the case, the surgical staff noticed a burning smell and thought it was coming from the surgical suction.They replaced the neptune in the room but noticed the smell was coming from the suction irrigator unit when changing out the fluid.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The root cause was fluid ingress causing a short inside of the motor.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was a thermal event.

• 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: 12333906
• MDR Text Key: 268376188
• Report Number: 0002936485-2021-00432
• 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: 10/03/2021

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: Health Professional
• Device Catalogue Number: 0250070520
• Device Lot Number: 21140FG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1