MAUDE Adverse Event Report: STRYKER ENDOSCOPY STRYKER INSUFFLATION TUBING; TUBING / TUBING WITH FILTER, INSUFLLATION LAPAROSCOPIC

Lot Number 56005247

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2019

Event Type  malfunction  

Event Description

Sds team opened one of the insufflation tubing and it was leaking around where it plugs into the machine.The lot #56005247, exp.Date 02/09/2020.This is in the team leaders office.

• Brand Name: STRYKER INSUFFLATION TUBING
• Type of Device: TUBING / TUBING WITH FILTER, INSUFLLATION LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY
• MDR Report Key: 8420638
• MDR Text Key: 138910096
• Report Number: MW5084890
• Device Sequence Number: 1
• Product Code: NKC
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Lot Number: 56005247
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1