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

Model Number	250-40
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
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 procedure, the device was given an impression to tear around the ring though there was no over pressure performed at that time.Replaced by a new device from another lot to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Testing of device from the same lot, returned from the user.Returned devices were sealed, but the account states it was used in the procedure.No abnormalities were found during visual inspection and functional testing of the returned product.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 analysis concluded there were no assembly component related conditions.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: ENDO BAG
• 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: 7458237
• Report Number: 2647580-2018-02065
• Device Sequence Number: 16529031
• Product Code: GCJ
• UDI-Device Identifier: 10884523000979
• UDI-Public: 10884523000979
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K913762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 12/31/2022
• Device Model Number: 250-40
• Device Catalogue Number: 250-40
• Device Lot Number: P7M1304X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 08/08/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1