MAUDE Adverse Event Report: COVIDIEN LLC SPACEMAKER PRO ACCESS AND DISSECTOR SYSTEM 10MM-12MM; LAPAROSCOPE GENERAL AND PLASTIC SURGERY

Model Number SMBTTOVLX

Device Problems Break (1069); Device Slipped (1584)

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

Event Date 05/06/2019

Event Type  malfunction  

Event Description

During procedure, surgeon utilized the spacemaker pro access and dissector system 10-12mm.The spacemaker piece #1 at the top of the trocar device broke off.The clips did not hold in place.The surgical team then brought a new spacemaker device to the procedural room and the same exact issue occurred as described above.Both devices had the same reference number, same lot number and same expiration date, all devices were pulled from service at the facility.Fda safety report id # (b)(4).

• Brand Name: SPACEMAKER PRO ACCESS AND DISSECTOR SYSTEM 10MM-12MM
• Type of Device: LAPAROSCOPE GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 8608432
• MDR Text Key: 145280134
• Report Number: MW5086617
• Device Sequence Number: 2
• Product Code: GCJ
• 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: 05/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: SMBTTOVLX
• Device Catalogue Number: SMBTTOVLX
• Device Lot Number: P8M1162Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR