MAUDE Adverse Event Report: STRYKER CORPORATION; INSUFFLATOR, LAPAROSCOPIC

Model Number 0620030407

Patient Problem Insufficient Information (4580)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

Insufflation tubing came apart.Poorly sealed, could not connect to trocars.

• Brand Name: NA
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical court; san jose CA 95138
• MDR Report Key: 18491052
• MDR Text Key: 332613363
• Report Number: 18491052
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327055627
• UDI-Public: (01)07613327055627(17)260503(10)23124FE2
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2023

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
• Device Model Number: 0620030407
• Device Catalogue Number: 620-030-407
• Device Lot Number: 23124FE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 68 KG