MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON; ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG, (PURPLE)

Catalog Number	H12LP2RH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the plastic sleeve of the reprocessed ethicon's endopath xcel blunt tip trocar, w/smooth sleeve and adjustable plug, (purple) 12mm x 100mm, broke off inside the patient during an unidentified case.Per report, the broken piece was successfully retrieved from the patient through an unspecified method.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident.Due to the reported event and required medical intervention to retrieve the broken piece from the surgical site, this medwatch is being filed.The device was returned for evaluation and the complaint was confirmed.A review of the reprocessing records was performed and indicated that all processes were conducted as required.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the plastic sleeve of the reprocessed ethicon trocar broke off inside the patient during an unidentified procedure.

• Brand Name: ETHICON
• Common Device Name: ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG, (PURPLE)
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8570159
• Report Number: 3032391-2019-00009
• Device Sequence Number: 1992009
• Product Code: NLM
• UDI-Device Identifier: 10888277356238
• UDI-Public: 10888277356238
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H12LP2RH
• Device Lot Number: 413307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention