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

Catalog Number	0620050000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).Wom has been made aware of this report event.
Event or Problem Description
It was reported that during insufflation, the patient's penis increased in size and split open.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation , the reported failure ¿the insufflator was not reading pressure correctly¿ was not confirmed.According to wom: visual inspection the device was received on oct 25, 2023 for evaluation.The device was shipped with the correct packaging, packaging was in good condition.The device is in good overall condition, however, there is a small dent on the right side.In addition, the silicon tubing on the exhaust port is broken.Stryker service seal found broken.Functional inspection initial self-test passed; no errors occurred.Full functional testing was performed, and all tests were found to be within tolerance, according to current test instructions v.7.0.No abnormalities were detected.The device was found to be functioning per specifications.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 u, sn (b)(6) is working according to specification.Probable root cause: the accumulation of gas in the scrotum, labium or the penis are very rare but can happen due to a tissue defect between the abdomen or the inguinal (leisten) and the genitals.In this case, having the device set at 15 mmhg for an inguinal hernia seems too high and might increase the risk for side effects.So it seems to be an issue caused by the settings of the user not being appropriate for the patient.However, the doctor does not believe the insufflator is at fault and to support this the device was evaluated by the manufacturer and found to be functioning as per specification.Nonetheless, the event description includes a defined risk to patient's health and led to patient injury requiring medical intervention.If the injury was permanent or temporary could not be determined due to availability of limited information at the time of reporting decision.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during insufflation, the patient's penis increased in size and split open.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18069848
• Report Number: 0002936485-2023-01109
• Device Sequence Number: 15346637
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• 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): 03/11/2024

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 Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male