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

Catalog Number 0620040601

Device Problem Gas Output Problem (1266)

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

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was converted to an open procedure.

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: displayed error message.Probable root cause: 1.Software malfunction; 2.Power supply malfunction; 3.Insufflator design; 4.Unwanted movement of internal components / wiring; 5.Use error; 6.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge; 7.Mio board malfunction; 8.Bam board malfunction; 9.Lcd assembly failure; 10.Manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the procedure was converted to an open procedure.

• Brand Name: PKG; PNEUMO SURE 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: 10485472
• MDR Text Key: 205455468
• Report Number: 0002936485-2020-00357
• 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: company representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other