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	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.Device analysis: the analysis results found that the bcd10 device was returned.Upon evaluation of the device, 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.In addition, the tip of the device was not returned.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 r40t8u number, and no non-conformances were identified.
Event or Problem Description
During cholecystectomy procedure, blunt dissectors were used.The cotton blunt tip of one of the dissectors came off and could not be found within the abdomen of the patient.Surgeon did a risk assessment and decided it would be better to close patient instead of converting to open surgery to search for the little cotton blunt tip.Surgeon expressed that the most likely scenario is that the patient will be fine and only develop a little ¿scar¿ or hardening of the surrounding tissue where the blunt tip ended up, but they will of course follow any post-operative events.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8569524
• Report Number: 3005075853-2019-18644
• Device Sequence Number: 2087119
• Product Code: MDM
• UDI-Device Identifier: 10705036011866
• UDI-Public: 10705036011866
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/18/2019

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: 07/31/2023
• Device Catalogue Number: BCD10
• Device Lot Number: R40T8U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1