MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620050250
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a conversion to open surgery.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The manufacture date is not known at this time.However, should it become available it will be provided in future reports.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.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: tube sets not recognized by the insufflator.Visual inspection: not possible because the actual devices involved in the adverse event were not returned for testing despite requests and had been already discarded and thus irretrievably lost for testing.Functional inspection: not possible because the actual devices involved in the adverse event were not returned for testing despite requests and had been already discarded and thus irretrievably lost for testing.However, testing was performed using the device-retained samples.All testing of the retained samples confirmed the conformance of the device i.E.All functions are according to specification including the tube set recognition.Dimensional inspection: not possible because the device was not returned for evaluation.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.Neither the tube sets nor the device used during this event have been returned for evaluation.However, we investigated the retention samples from the same lot and the samples corresponded to the specification they could be inserted into the insufflator and recognized without any problems.Since there are no complaints about the pneumoclear insufflator with tube sets from different lots reported we cannot exclude a malfunction of the used tube sets for this procedure.Nonetheless, the event description includes a defined risk to the patient's health and led to conversion to open surgery (open procedure).The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was a conversion to open surgery.

• Brand Name: PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET
• 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: 18818488
• Report Number: 0002936485-2024-00190
• Device Sequence Number: 12829811
• Product Code: HIF
• UDI-Device Identifier: 04056702001490
• UDI-Public: 04056702001490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/09/2024

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: 0620050250
• Device Lot Number: 4030185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown