MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040611

Device Problem Device Alarm System (1012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

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 potential for a procedure delay greater than 30 minutes.The procedure was completed successfully.

Manufacturer Narrative

The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker uk.The technical service report is attached (see communication log), and indicates: repair/service notes 16 sep 20 - upon attendance it was noted that the unit had recently been returned from repair - identified issue as being that the black 'latch for snap in connector f114' was missing - installed replacement black 'latch for snap in connector f114' - fault resolved - fsp passed qip/pip status: passed probable root cause: system design manufacturing / assembly/ service error use error damage during shipping tubeset locking mechanism malfunction the reported failure mode will be monitored for future reoccurrence.81.

Event Description

It was reported that there was a potential for a procedure delay greater than 30 minutes.The procedure was completed successfully.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10673730
• MDR Text Key: 212532808
• Report Number: 0002936485-2020-00421
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1