MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 2/3 MM TROCAR 65MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	23NBS
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: r9553m.Investigation summary: the analysis results found that a 23nbs device was received for analysis.The analysis results found that a 23nbs device was received with the outer gasket torn.In addition, a petri dish with the piece of outer gasket torn was received.Upon visual inspection with magnification, the outer gasket was confirmed to have evidence of cuts.A possible cause for this damage is the use of sharp instruments during the procedure.Use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the gaskets which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.
Event or Problem Description
It was reported that during a total prostatectomy procedure, a foreign matter like "a piece of the valve was found inside the package during use.It was retrieved from the patient." the procedure was not converted to an open procedure.It is unknown why the issue occurred.Another package was opened to compare the device with the complaint device, then it was found the part of the valve was broken.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: 2/3 MM TROCAR 65MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12478833
• Report Number: 3005075853-2021-05501
• Device Sequence Number: 14411551
• Product Code: GCJ
• UDI-Device Identifier: 10705036000402
• UDI-Public: 10705036000402
• Combination Product (Y/N): N
• PMA/510(K) Number: K972578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 23NBS
• Device Catalogue Number: 23NBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1