MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS); INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/31/2020

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 into open surgery.

Manufacturer Narrative

This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿smoke causing poor visualization.¿ was not confirmed.According to wom: visual inspection the device was received on feb 20, 2020 for evaluation.There are no indications of transport damage.The unit is in good condition.Functional inspection: further functional testing based on the actual valid final test instruction indicated the device passed to meet the criteria.All tests were found to be within tolerance.This included the suction test with each pass.Dimensional inspection: due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion: the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#: 0620050000 rev t, sn: (b)(6) is working according to specification.Probable root cause: it was reported that the patient was very sick, and the procedure was scheduled for a potential open procedure from the beginning.It can be assumed that a single incident which leads to a worsening of the general situation made the surgeon to decide to convert to open.The device was returned and evaluated, and the smoke evacuation was found to be working as specified.The conducted general function test passed as well.With the given information it can be concluded that the most probable root cause for the limited smoke evacuation performance is likely a setup related issue.It was stated by the complainant that the smoke evacuation line was connected to the trocar in which also the cautery device was being used.Smoke evacuation was connected to a 5 mm trocar.A 5 mm trocar with a cautery device inserted will most likely not allow for sufficient smoke evacuation if it works at all.The scope port was a 12 mm trocar.Usage of a 12 mm trocar for insufflation and either an empty 5 mm trocar or a 1 0 mm trocar with a smaller instrument inserted should allow for decent evacuation of surgical smoke.Nevertheless, the clearance performance has limitations, so if very heavy cautery is used it might take some time for the plume to clear.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the procedure was converted into open surgery.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9712883
• MDR Text Key: 179481857
• Report Number: 0002936485-2020-00064
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other