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 Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
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, on a laparoscopic totally extraperitoneal, when inserting the balloon into the preperitoneal tissue and trying do dilate the space in the groin area, the balloon did not inflate.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the dissector balloon, trocar balloon, obturator and insufflation bulb appeared intact.The inflation syringe was not received.The lock collar tab was broken and the pieces were received.Pmv performed functional testing; using a test syringe the trocar balloon was inflated, no leaks detected.The dissector balloon was inflated, 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.Analysis concluded there were no assembly component related failures.Additionally, the investigation detected a secondary condition of broken lock collar that has no relationship to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: the dissector balloon, trocar balloon, obturator and insufflation bulb appeared intact.The inflation syringe was not received.The lock collar tab was broken and the pieces were received.A functional evaluation found that using a test syringe the trocar balloon was inflated, dried fluids were noted and the balloon showed signs of resisting to inflate.The balloon was provided more air from the syringe and popped upon examination.The dissector balloon was inflated, no leaks detected.A review of the device history record indicates this product was 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.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No enhancements or improvements were generated for 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: 8704531
• Report Number: 2647580-2019-03075
• Device Sequence Number: 2268113
• Product Code: GCJ
• UDI-Device Identifier: 10884521067837
• UDI-Public: 10884521067837
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 09/23/2019

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: 07/31/2020
• Device Model Number: SMSBTRND
• Device Catalogue Number: SMSBTRND
• Device Lot Number: P8G0126X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 08/28/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/28/2019; 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1