MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X75MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2CB5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary the analysis results found that the 2cb5st device was returned with no damage in the external components.The valve opened and closed without any difficulties.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 valve was broken off.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: OPT SLEEVE 5X75MM STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9339510
• Report Number: 3005075853-2019-23578
• Device Sequence Number: 16677569
• Product Code: GCJ
• UDI-Device Identifier: 10705036013747
• UDI-Public: 10705036013747
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• 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): 10/27/2019

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: 07/31/2024
• Device Catalogue Number: 2CB5ST
• Device Lot Number: T40R1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 10/27/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1