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

Model Number	2CB12LT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a nephrectomy procedures, the trocar sleeve is disassembled.There was no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Unknown, assumed 1st day of month that the event took place.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide more details about statement ¿please inspect the input to rule out any broken and/or missing parts¿ did any piece or pieces were separated from the device? if yes, did a piece or pieces fall into the patient? if yes, were they retrieved? if yes, are they being returned with the device? if not, were they disposed of? if other, please specify.
Additional Manufacturer Narrative
(b)(4) date sent: 6/17/2022 investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that 2cb12lt device was returned inside its package opened and with the universal seal unlatched from the sleeve.In an attempt to replicate the reported incident, the packaging was opened and the device was functionally tested to detect any issues.Upon evaluation of the device, the universal seal latch onto the sleeve assembly.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.

• Brand Name: OPT SLEEVE 12X100 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14364325
• Report Number: 3005075853-2022-03079
• Device Sequence Number: 14491906
• Product Code: GCJ
• UDI-Device Identifier: 10705036014263
• UDI-Public: 10705036014263
• Combination Product (Y/N): N
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 01/31/2025
• Device Model Number: 2CB12LT
• Device Catalogue Number: 2CB12LT
• Device Lot Number: 644A35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown