MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OPERATIVE LAP TUBAL PACK

Catalog Number DYNJ62808B

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of the covidien trocar device was left inside of a patient during an unspecified procedure.The facility reported that the device was introduced into the patient with the tip intact and when the trocar was pulled out the tip was missing.The tip was not located or retrieved.There was no known impact to the patient or the procedure.The procedure was completed without further incident.No additional information is available.The trocar device was not returned for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the covidien trocar device fell off during an unspecified patient procedure and was left inside of the patient.

• Type of Device: OPERATIVE LAP TUBAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 9557774
• MDR Text Key: 190761550
• Report Number: 1423395-2019-00049
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ62808B
• Device Lot Number: 19KBB786
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 64