MAUDE Adverse Event Report: COVIDIEN LP SPACEMAKER PLUS; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	SMSBTOVL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Spacemaker plus dissector system was faulty during procedure.The balloon end was not inflating inside the abdominal cavity.A new device was opened and the procedure was completed successfully.No harm came to the patient.Manufacturer response for laparoscope, general plastic surgery, spacemaker plus (per site reporter).Information was sent to quality and field rep.Awaiting reply and return kit.

• Brand Name: SPACEMAKER PLUS
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9575249
• Report Number: 9575249
• Device Sequence Number: 2866966
• Product Code: GCJ
• UDI-Device Identifier: 10884521067820
• UDI-Public: (01)10884521067820
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2019
• Report Date (Section F): 11/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: SMSBTOVL
• Device Catalogue Number: SMSBTOVL
• Device Lot Number: P9A1599Y
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/15/2019