MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT DILATING 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2D12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, the blade was stuck out of the trocar and cannot push red button.It is unknown how the procedure was completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/22/2020.D4: batch #t93h8j.Investigation summary: the analysis results found that the 2d12lt device was returned with no damage in the external components.During the functional testing, the bullet retracted, permitting the exposure of the blade during the advancement through the skin test media, and returned to safe position upon penetration.The bullet performed as intended without any anomalies noted.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: OPT DILATING 12X100 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9770683
• Report Number: 3005075853-2020-01334
• Device Sequence Number: 2910022
• Product Code: GCJ
• UDI-Device Identifier: 10705036014232
• UDI-Public: 10705036014232
• Combination Product (Y/N): N
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 05/08/2024
• Device Model Number: 2D12LT
• Device Catalogue Number: 2D12LT
• Device Lot Number: T40U5P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 06/22/2020
• Patient Sequence Number: 1