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

Model Number	SMCYLCST
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
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 a laparoscopic, endoscopic component separation, when the balloon was placed to create the space between the externus and internus aponeurosis, the balloon did not inflate.Another device was opened and 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 noted: that the dissector balloon and insufflation bulb, lock collar, trocar balloon and obturator appeared intact.The inflation syringe was not received.The circular seal for the dissector balloon was cut.A functional evaluation found that pmv performed functional testing; using a test syringe the trocar balloon was inflated, no leaks detected.The hole for the dissector balloon was covered, the 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.Replication of the cut in the circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed 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.

• Brand Name: SPACEMAKER
• 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: 7893446
• Report Number: 2647580-2018-04615
• Device Sequence Number: 16731094
• Product Code: GCJ
• UDI-Device Identifier: 20884521545332
• UDI-Public: 20884521545332
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151356
• 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): 11/27/2018

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: 06/30/2019
• Device Model Number: SMCYLCST
• Device Catalogue Number: SMCYLCST
• Device Lot Number: P7F1178X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/03/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1