MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2CB5LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/22/2024.D4: batch # unk.Additional information was requested and the following was obtained: could you please specify how the device was damaged? was the outer seal damaged? was the inner seal damaged? was the stopcock damaged? any visible broken part? if other, please specify " left with no more specific details.I took a visual of the trocar and did not see any visible damage." 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the trocar valve was not working.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/12/2024.D4: batch # unk.Investigation summary: the product was returned to ethicon for evaluation. visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that 2cb5lt device was returned with no apparent damage.In addition, the packaging opened was returned along with the instrument.In an attempt to replicate the reported incident, the device was functionally tested to detect any leaking issues.Upon evaluation of the device, it was functionally leak tested and passed.The device was fully functional according to the manufacturing requirements. 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 lot number, and no non-conformances were identified.

• Brand Name: OPT SLEEVE 5X100MM 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18763862
• Report Number: 3005075853-2024-01563
• Device Sequence Number: 7795039
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: 10705036013730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• 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): 03/12/2024

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 Catalogue Number: 2CB5LT
• Device Lot Number: 672C44
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown