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

Model Number	2CB5LT
Medical Device Problem Codes	Crack (1135); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, assumed first day of the year the complaint was reported.Batch # unk.Additional information was requested and the following was obtained: "the very top of the sleeve close to the housing is what broke.Insufflation was impacted but the trocar broke during insertion after the port sites were made so this wasn¿t an issue".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 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 broke during insertion into the port site.Surgeon thought he put too much pressure on it as he inserted it.No patient injury and no fragments were generated.The case was successfully completed.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16113336
• Report Number: 3005075853-2023-00131
• Device Sequence Number: 5743588
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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 Model Number: 2CB5LT
• Device Catalogue Number: 2CB5LT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/06/2023
• 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