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

Catalog Number	23NBS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.As a lot/batch was not provided, a device history could not be performed.
Event or Problem Description
It was reported that during a laparoscopic unknown procedure, a foreign piece like a part of the valve was found on the shaft of a forceps when the forceps was removed from the patient through the device.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Possible batch # n9111r, r92c0g.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.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.The batch history record was reviewed and identified a loss of air defect related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.The final quality release criteria were met before this batch was released for distribution.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

• 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: 8051304
• Report Number: 3005075853-2018-14252
• Device Sequence Number: 1586423
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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: 23NBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/10/2018
• Patient Sequence Number: 1