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	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Investigation summary: the analysis results found that the bcd10 device was returned with the cotton tip loose and with dry body fluid present.Upon evaluation, evidence of adhesive was found on 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.It is possible that the damage to the device was due to improper handling.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported by the sales rep that during a laparoscopic pneumonectomy, a cotton tip fell off during use.The device was used on the lung.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: 9447059
• Report Number: 3005075853-2019-24147
• Device Sequence Number: 502059
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: BCD10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1