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

Catalog Number	2D12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) medical device: batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that after the blade was pressed, the yellow tab didn¿t come back to its place.So, the knife was exposed after its first penetration.There were no patient consequences.It is unknown if the surgery was delayed.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
(b)(4).Batch # r95443.Investigation summary: the analysis results found that the 2d12lt device was returned with no damage in the external components.During functional testing, the bullet retracted, permitting the exposure of the blade during the advancement through the skin test media and it returned to safe position upon penetration.The bullet performed as intended without any anomalies noted.It could not be determined what may have caused the event reported.The event described could not be confirmed as the device performed without any difficulties noted and the reported complaint could not be confirmed.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: 8658439
• Report Number: 3005075853-2019-19427
• Device Sequence Number: 2274778
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 11/30/2023
• Device Catalogue Number: 2D12LT
• Device Lot Number: T4034V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 11/19/2019
• Patient Sequence Number: 1