MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*BLUNT CHERRY DISSECT; BLUNT CHERRY DISSECTOR

Catalog Number	BCD10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Per photographic evaluation: upon visual inspection, the tip of the sample appears to be separated.There appears to be evidence the cotton tip being properly attached to the shaft; however, no definitive conclusion could be reached as to the cause of the reported incident as the device was not returned for analysis.The photo does not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Device analysis: the analysis results found that the shaft of a bcd10 devices was returned for analysis.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.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.
Event or Problem Description
It was reported that during a urology procedure, at the or the tip broke off in the belly.The procedure was delayed by 10 minutes.A new product was opened.

• Common Device Name: BLUNT CHERRY DISSECTOR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7955845
• Report Number: 3005075853-2018-13463
• Device Sequence Number: 1682184
• Product Code: MDM
• UDI-Device Identifier: 20705036011863
• UDI-Public: 20705036011863
• 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): 08/21/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: BCD10
• Device Lot Number: P4T90L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1