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

Model Number	OMS-XB1
Medical Device Problem Codes	Detachment Of Device Component (1104); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
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 hernia procedure, the trocar broke and a piece disengaged into the patient's cavity but was retrieved from the patient.There was no patient injury.
Additional Manufacturer Narrative
Additional info: evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the balloon, cannula, valve doors and insufflation port appeared intact.The obturator was received.The insufflation bulb was not received.The protective sheath for the balloon was disengaged.Pmv performed functional testing, the hole was covered, and the balloon was inflated using a test insufflation bulb, 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 disengaged protective sheath 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.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTRA VIEW
• 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: 7531226
• Report Number: 2647580-2018-02631
• Device Sequence Number: 19245663
• Product Code: GCJ
• UDI-Device Identifier: 20884521068022
• UDI-Public: 20884521068022
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K954175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 06/30/2020
• Device Model Number: OMS-XB1
• Device Catalogue Number: OMS-XB1
• Device Lot Number: P7F1598X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 08/08/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 07/23/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1