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	Foreign Body In Patient (2687)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.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.
Event or Problem Description
It was reported that there was an issue with er223r - recamier uter.Curette sh/rig.#3 12.0mm.According to the complaint description, the product fractured inside the patient and required additional surgery.An additional medical intervention was necessary.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Updated: b3 event date, b5 event description, e1 and e2 reporter.
Event or Problem Description
Additional information: 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: 11568164
• Report Number: 9610612-2021-00308
• Device Sequence Number: 17178445
• Product Code: HCY
• UDI-Device Identifier: 04038653041800
• UDI-Public: 4038653041800
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 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