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

Model Number	0620040600
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was inlet gas pressure issue during the procedure.The procedure was completed successfully.
Event or Problem Description
It was reported that there was inlet gas pressure issue during the procedure.The procedure was completed successfully.
Additional 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
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10673365
• Report Number: 0002936485-2020-00418
• Device Sequence Number: 3312874
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 0620040600
• Device Catalogue Number: 0620040600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1