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

Model Number	23NBS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not provided.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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 a herniorraphy, the surgeon used 2-3mm trocar and noticed what seemed to be shards of plastic in trocar.Surgeon pulled them out and saved them, and though fragments were generated, they were easily removed without additional intervention.The case was successfully completed with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/12/2020.D4: batch #u9337k.Investigation summary the analysis results found that the 23nbs device was returned with no apparent damage.In addition, two plastic pieces were received inside of a plastic bag.The event could not be confirmed, as the pieces of plastic did not belong to the trocar.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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
• MDR Report Key: 10251946
• Report Number: 3005075853-2020-03449
• Device Sequence Number: 11605676
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 12/30/2024
• Device Model Number: 23NBS
• Device Catalogue Number: 23NBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1