MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number 0620040600

Device Problems Calibration Problem (2890); Pressure Problem (3012)

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

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was inlet gas pressure issue during the procedure.The procedure was completed successfully.

Event Description

It was reported that there was inlet gas pressure issue during the procedure.The procedure was completed successfully.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: "calibrate to current specs, upgrade software, 90 day repair warranty".Probable root cause: software malfunction; power supply malfunction; insufflator design; unwanted movement of internal components / wiring; use error; electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge; mio board malfunction; bam board malfunction; lcd assembly failure; manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PKG; PNEUMO SURE HIGH FLOW INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10673365
• MDR Text Key: 212467931
• Report Number: 0002936485-2020-00418
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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 Model Number: 0620040600
• Device Catalogue Number: 0620040600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1