MAUDE Adverse Event Report: AESCULAP AG UTERINE CANNULAE W/2 CONES LGTH 330MM; CATHETER, FEMORAL

Model Number	ER876
Medical Device Problem Codes	Disconnection (1171); Separation Problem (4043)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with er876 - uterine cannulae w/2 cones lgth 330mm.According to the report mw5099049, detachment of device componenet during procedure.Undetected.Retained foreign body following procedure.Patient had an outpatient laparoscopic left ovarian cystectomy.During procedure a cohen uterine manipulator was used with an acorn top.During the procedure the acorn tip became disconnected from the manipulator.This was not detected during the procedure.Patient was dispositioned home.Returned to provider clinic the next day with complaints of vaginal fullness.Vaginal exam performed and ecorn tip discovered and removed with no harm to patient.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were not able to be reviewed as the lot number was not made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
No change.

• Brand Name: UTERINE CANNULAE W/2 CONES LGTH 330MM
• Common Device Name: CATHETER, FEMORAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11516144
• Report Number: 2916714-2021-00039
• Device Sequence Number: 14305895
• Product Code: LFK
• UDI-Device Identifier: 04038653042449
• UDI-Public: 4038653042449
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021
• Report Date (Section F): 03/18/2021

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 Model Number: ER876
• Device Catalogue Number: ER876
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 03/18/2021