MAUDE Adverse Event Report: AESCULAP AG UTERINE CANNULAE W/2 CONES LGTH 330MM; GYNAECOLOGY AND OBSTETRICS

Model Number	ER876
Medical Device Problem Codes	Disconnection (1171); Material Fragmentation (1261); Separation Problem (4043)
Health Effect - Clinical Code	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 complaint description, the acorn tip of the cannula disconnected during surgery.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.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - block a3 investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: UTERINE CANNULAE W/2 CONES LGTH 330MM
• Common Device Name: GYNAECOLOGY AND OBSTETRICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11516210
• Report Number: 9610612-2021-00187
• Device Sequence Number: 3280790
• Product Code: LFK
• UDI-Device Identifier: 04038653042449
• UDI-Public: 4038653042449
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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