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

Model Number	SMSBTOVL
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A spacemaker plus dissector system was opened and it was discovered that the seal on the dissector balloon was open, causing it to fall off the apparatus.Another product of same type was brought into the or and performed as expected.There was no harm to the patient and no delay in procedure.Manufacturer response for laparoscope, general plastic surgery, spacemaker plus (per site reporter).The device will be returned for failure analysis.

• Brand Name: SPACEMAKER PLUS
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9659263
• Report Number: 9659263
• Device Sequence Number: 3319896
• 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): 01/10/2020
• Report Date (Section F): 01/10/2020

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: No Information
• Device Model Number: SMSBTOVL
• Device Catalogue Number: SMSBTOVL
• Device Lot Number: P9G0856Y
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94
• Date Report Sent to FDA: 01/10/2020