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

Model Number	BCD10
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u4007e.Investigation summary.The analysis results found that the bcd10 device was returned with the cotton tip loose and with dried body fluid on device.Upon evaluation, evidence of adhesive was found on the tip of the shaft and the cotton appears to have been pulled off.The damage to the device possibly occurred due to an improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic hysterectomy, the cotton tip fell off during use.The fallen piece was retrieved.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 ; * 00969
• MDR Report Key: 10137724
• Report Number: 3005075853-2020-02954
• Device Sequence Number: 19397207
• 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): 06/09/2020

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: 12/31/2024
• Device Model Number: BCD10
• Device Catalogue Number: BCD10
• Device Lot Number: U4007E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/10/2020
• Patient Sequence Number: 1