MAUDE Adverse Event Report: COVIDIEN TROCAR CATH 24FR

Model Number	8888561050-
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the tip of the device remained in the chest of the patient.Additional information was received stating that the trocar was removed from the patient endoscopically before the start of the operation and the patient was fine.
Additional Manufacturer Narrative
There were two photographs submitted with the complaint, which have been reviewed.From the review, we cannot confirm the reported issue based on the x-ray photographs provided.The complaint report indicates that there is no sample available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If additional information or samples are received, the investigation will resume as needed.
Additional Manufacturer Narrative
The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The complaint report indicates that there is no sample available in connection with this complaint report.There were two photographs submitted with the the complaint which have been reviewed; from the review it is hard to see the tip, but it is just above the hand symbol in the photo.From the review we can confirm the reported issue.However, without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).If additional information or samples are received, the investigation will resume as needed.

• Brand Name: TROCAR CATH 24FR
• Common Device Name: TROCAR
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; tullamore, co, offaly ; EI
• MDR Report Key: 9717915
• Report Number: 9612030-2020-02415
• Device Sequence Number: 13535468
• Product Code: DRC
• UDI-Device Identifier: 10884521029293
• UDI-Public: 10884521029293
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2020

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: No Information
• Device Model Number: 8888561050-
• Device Catalogue Number: 8888561050-
• Device Lot Number: 18G250FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 02/12/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/20/2020; 05/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other