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

Model Number	FM300
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Dyspnea (1816); Infiltration into Tissue (1931)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.Filling on behalf of world of medicine (wom).
Event or Problem Description
It was reported that the patient experienced subcutaneous emphysema and crepitus.
Event or Problem Description
It was reported that the patient experienced subcutaneous emphysema and crepitus.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿robotic cases of subcutaneous emphysema and crepitus¿ was not confirmed.According to wom: visual inspection the device was received on sep 13, 2021 for evaluation.There are no indications of transport damage or misuse.Functional inspection: functional inspection based on test instructions v 6.0 indicated the returned device passed all criteria.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#620050000, sn (b)(6) is working according to specification.Probable root cause: there are no indications of a manufacturing issue.The events, all reported by the same hospital, are all well-known side effects which can occur during laparoscopic procedures and can be well controlled by the or team in terms of e.G., trocar placement, patient ventilation, positioning, and insufflator settings.The most probable root cause is that the user may not have chosen a suitable pressure for the respective patient or did not adjust the settings during a potentially prolonged procedure accordingly, as well as may not have ideally positioned the patient or patient ventilation may have been insufficient.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12333907
• Report Number: 0002936485-2021-00431
• Device Sequence Number: 14136412
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other