MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SPACEMAKER PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SMSBTRND
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted; the trocar balloon, obturator and lock collar all appeared intact.The insufflation bulb was received.The dissector balloon and inflation syringe were not received.Pmv performed functional testing: the trocar balloon was inflated; no leaks detected.All other components functioned properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic tep hernia repair procedure, the device did not inflate.Another device was opened to complete the procedure.No patient injury has been noted.

• Brand Name: SPACEMAKER PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7082751
• Report Number: 2647580-2017-08291
• Device Sequence Number: 13927103
• Product Code: GCJ
• UDI-Device Identifier: 10884521067837
• UDI-Public: 10884521067837
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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 Expiration Date: 01/31/2019
• Device Model Number: SMSBTRND
• Device Catalogue Number: SMSBTRND
• Device Lot Number: P7A0463X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1