MAUDE Adverse Event Report: AESCULAP AG UTERINE CANNULAE W/2 CONES LGTH 330MM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number	ER876
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental mdr will be provided.
Event or Problem Description
It was reported to aesculap inc.That a uterine cannulae w/2 cones lgth 330mm (part # er876) device problem was experienced.According to the complainant, the instructions for use (ifu) document is inadequate.The device was unable to be thoroughly cleaned.Residual bioburden was found in the shaft of the probe and inside the cone.No patient involvement was reported.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4) and under fda reference mw5099373.Involved components: er876201 - cone small f.Er876 - lot unknown, er876202 - cone big f.Er876 - lot unknown, fremd010 - foreign article apg010 - lot unknown.
Additional Manufacturer Narrative
Additional information/correction: according to review of the investigation, this event is considered no longer reportable for the following reason: the patient harm was updated, and the failure mode risk analysis has been adjusted to severity of 2(5).H6 - codes updated involved components: 400508640 - er876201.400508641 - er876202.400508813 - wolf-8378-00 (updated).Investigation: 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 must remain incomplete.The review of risk assessment revealed that the overall risk level (severity 2(5) xprobability of occurrence 2(5)) 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 on the investigation results, a capa is not necessary.

• Brand Name: UTERINE CANNULAE W/2 CONES LGTH 330MM
• Common Device Name: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11703831
• Report Number: 9610612-2021-00319
• Device Sequence Number: 11761861
• Product Code: LKF
• UDI-Device Identifier: 04038653042449
• UDI-Public: 4038653042449
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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
• 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: 03/25/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown