MAUDE Adverse Event Report: STRYKER ENDOSCOPY PNEUMOCLEAR INSUFFLATION TUBING; INSUFFLATOR, LAPAROSCOPIC

Lot Number 4020373

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  Injury  

Event Description

Stryker pneumoclear insufflation tubing did not work/emit gas.Exchanged for another tubing.Fda safety report id# (b)(4).

• Brand Name: PNEUMOCLEAR INSUFFLATION TUBING
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY; san jose CA 95138
• MDR Report Key: 13514267
• MDR Text Key: 285549056
• Report Number: MW5107387
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2022

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
• Device Operator: Health Professional
• Device Lot Number: 4020373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White