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

Model Number	SMCYLCST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic component separation procedure.During the placement of the balloon and the removal of the obturator to place the scope, the plastic top of the obturator broke off.There was enough obturator left exposed to grab it with hand and remove it.There was no rapid loss of abdominal pressure due to the device issue.There was no patient harm.The patient outcome is alive, no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned products noted; the top of the obturator was disengaged.The sponge on the lock collar was disengaged.The trocar balloon and dissector balloon appeared intact.The inflation syringe was not received.The insufflation bulb was received.Pmv performed functional testing: the trocar balloon could not be inflated due to a hole in the balloon.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.Replication of the top of the obturator being disengaged may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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.

• Brand Name: SPACEMAKER PRO
• 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: 6769938
• Report Number: 2647580-2017-05869
• Device Sequence Number: 10983278
• Product Code: GCJ
• UDI-Device Identifier: 20884521545332
• UDI-Public: 20884521545332
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

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: 10/31/2018
• Device Model Number: SMCYLCST
• Device Catalogue Number: SMCYLCST
• Device Lot Number: P6K0011X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/06/2017
• Supplement Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 159