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

Model Number	SMSBTOVL
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during left inguinal hernia surgery, the balloon did not inflate during surgery.Another balloon was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned products noted that the obturators, lock collars, trocar balloons and dissector balloons were received and appeared to be intact.The inflation syringes were received.The insufflation bulbs were received.The circular seal for the dissector balloons appeared intact.A functional evaluation found that the trocar balloons were inflated with no leaks detected.The dissector balloons were inflated with no leaks detected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 9519712
• Report Number: 2647580-2019-06314
• Device Sequence Number: 2851558
• Product Code: GCJ
• UDI-Device Identifier: 10884521067820
• UDI-Public: 10884521067820
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K042412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SMSBTOVL
• Device Catalogue Number: SMSBTOVL
• Device Lot Number: P9G1231Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 72