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

Model Number	23NBS
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u94l9p.Date of event is unknown.(b)(4).Investigation summary: the analysis results found that 23nbs device was received without the original packaging.In addition, the obturator was returned damaged (bent).Due to the damages found on the device, the complaint is confirmed.A possible cause for these conditions is due to improper handling during use of the device.Use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage.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 lot/batch number and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the device could not be inserted 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: 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: 12334736
• Report Number: 3005075853-2021-04758
• Device Sequence Number: 4542796
• 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): 07/28/2021

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: 07/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/17/2021
• Patient Sequence Number: 1