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	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.
Event or Problem Description
It was reported that during a laparoscopic unknown procedure, the outer seal of the valve fell off during use.The valve was broken outside the patient¿s body.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).Batch # unk.Additional information received: a photo was received for analysis.The photo shows a trocar device from top view and no defects could be observed.Based on the photo alone, the event described cannot be confirmed.Hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Investigation summary the analysis results found that a 23nbs device was received with the outer gasket torn.In addition, a piece of the torn outer gasket was received inside of a plastic jar.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.A review of the lot/batch history record could not be performed (lot unknown).

• 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: 9362809
• Report Number: 3005075853-2019-23702
• Device Sequence Number: 11387747
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 11/28/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/02/2019
• Patient Sequence Number: 1