MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*BLUNT CHERRY DISSECT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	BCD10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r41348.Device analysis: the analysis results found that the shaft of a bcd10 devices was returned and a plastic bag with the tip of the device.Upon evaluation, the dissector tip was found separated from the shaft, evidence of adhesive was found in the tip of the shaft as the cotton appears to have been pulled off.No conclusion could be reached as to what may have caused the reported incident.The complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot/batch r41348 number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic pneumonectomy, the cotton tip fell into the patient easily.The device was used on the lung.The fallen tip was retrieved, and no pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8667647
• Report Number: 3005075853-2019-19418
• Device Sequence Number: 284962
• Product Code: MDM
• UDI-Device Identifier: 10705036011866
• UDI-Public: 10705036011866
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: BCD10
• Device Lot Number: R41348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1