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	09/02/2019
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, when the balloon was inserted into the abdomen during a laparoscopic bilateral inguinal hernia, the balloon did not inflate.It was stated that the surgeon felt something changed with the balloon and felt the quality of the balloon has reduced.The balloon never inflated no matter how many times they pumped air into the bulb.A second balloon was opened and the same issue occurred.A third balloon was opened to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photos noted: the first image depicts the dissector balloon, it's bloodied and not inflated.The obturator is lying next to the balloon.The second image depicts the dissector balloon with the insufflation bulb attached.The balloon is bloodied and not inflated.The third image depicts two insufflation bulbs, one is attached to the uninflated dissector balloon.There are many surgical devices also in the image.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: 9124343
• Report Number: 2647580-2019-04786
• Device Sequence Number: 2528008
• Product Code: GCJ
• UDI-Device Identifier: 10884521067820
• UDI-Public: 10884521067820
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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 Expiration Date: 12/31/2020
• Device Model Number: SMSBTOVL
• Device Catalogue Number: SMSBTOVL
• Device Lot Number: P9A1599Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1