MAUDE Adverse Event Report: AESCULAP AG RECAMIER UTER.CURETTE SH/RIG.#3 12.0MM; GYNAECOLOGY AND OBSTETRICS

Model Number	ER223R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2019
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 to aesculap inc.That a recamier uterine curette #3 (part # er223r) was used during an unknown procedure performed on (b)(6) 2019.According to the complainant, the device fractured inside of the patient which required additional surgery.The complaint device was not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: due to a lack of the product, an investigation is not possible.Pictorial documentation: due to a lack of the product, a pictorial documentation 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.Explanation and rationale: based on the provided information, and without a product for investigation, a clear conclusion cannot be drawn.There is no capa request necessary.
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Updated: b3 event date, b5 event description,d2, e1 and e2 reporter.
Event or Problem Description
The patient underwent a dilation and curettage for a molar pregnancy.The curette fractured, broke, cracked and/or splintered inside of the patient.Due to this malfunction, an abdominal laparoscopy and hysteroscopy was performed.Further details were not provided.

• Brand Name: RECAMIER UTER.CURETTE SH/RIG.#3 12.0MM
• Common Device Name: GYNAECOLOGY AND OBSTETRICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11344714
• Report Number: 2916714-2021-00004
• Device Sequence Number: 5036625
• Product Code: HCY
• UDI-Device Identifier: 04038653041800
• UDI-Public: 4038653041800
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2021
• Report Date (Section F): 02/18/2021

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: ER223R
• Device Catalogue Number: ER223R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/30/2021; 10/27/2021
• 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: 02/18/2021