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	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.Device analysis: the analysis results found that the shaft of a bcd10 devices was returned and a petri dish 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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance's.
Event or Problem Description
It was reported that during a laparoscopic procedure, the cotton tip was fell off when the device was being removed from the patient via a trocar.The fallen tip was retrieved with a forceps and no pieces were left inside the patient.

• Common Device Name: BLUNT CHERRY DISSECTOR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7891674
• Report Number: 3005075853-2018-12870
• Device Sequence Number: 13482446
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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 Catalogue Number: BCD10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• Patient Sequence Number: 1