MAUDE Adverse Event Report: THE OR COMPANY LLC; INSUFFLATOR TUBING SET

Catalog Number TM6000

Device Problem Complete Blockage (1094)

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

Event Date 12/18/2018

Event Type  malfunction  

Event Description

During use, the insufflation tubing occluded.

• Type of Device: INSUFFLATOR TUBING SET
• Manufacturer (Section D): THE OR COMPANY LLC; 1625 tacoma way; tacoma WA 98409
• MDR Report Key: 8256417
• MDR Text Key: 133352772
• Report Number: 8256417
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TM6000
• Device Lot Number: 1727955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9490 DA