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	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.Device analysis: the analysis results found that a 23 nbs device was received with the outer gasket torn.In addition, the tyvek was returned along with the instrument and 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 lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.Additional information was requested and the following was obtained: was the foreign matter found in the pkg prior to use of the device? since the device was received at (b)(4), it was checked and found that the piece was a part of the seal.Did any pieces of the device fall into the patient? no.No further information will be provided.
Event or Problem Description
It was reported that during a laparoscopic urological procedure, a foreign matter was found during use.It was unknown whether the foreign matter was a part of the device, or not.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 7809949
• Report Number: 3005075853-2018-12310
• Device Sequence Number: 1176101
• Product Code: GCJ
• UDI-Device Identifier: 20705036000409
• UDI-Public: 20705036000409
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: No Information
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 23NBS
• Device Lot Number: R40228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/23/2018
• Patient Sequence Number: 1