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

Model Number	BTD05
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy the customer used an endopath 5mm blunt tip dissector.While removing the device, the fiber tip came undone and got lodged in the trocar.The procedure was successfully completed.There were fragments generated and the trocar had to the disassembled.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the btd05 devices was returned and a plastic bag with the tip of the device.In addition, the packaging opened was returned.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.Additional information was requested, and the following was obtained: please clarify: ¿were fragments generated? yes,¿ did any pieces fall into the patient? no.They got stuck in the trocar if yes, were they retrieved? yes.Will all pieces be returned with the device? yes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: ENDOPATH*BLUNT TIP DISSECTOR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15218968
• Report Number: 3005075853-2022-05258
• Device Sequence Number: 14889597
• Product Code: MDM
• UDI-Device Identifier: 10705036011873
• UDI-Public: 10705036011873
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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 Model Number: BTD05
• Device Catalogue Number: BTD05
• Device Lot Number: 613A53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown