MAUDE Adverse Event Report: AESCULAP AG SIMS UTERINE CURETTE #2 SHARP 255MM; SCOOPS AND CURETTES

Model Number	ER402R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a sims uterine curette #2 sharp 255mm (part # er402r) was used during a procedure on (b)(6)2023.According to the complainant the weld broke near the distal end at the working end and needed to retrieved from abdominal area.An x ray scan was performed afterwards to verify nothing was left inside the patient.It was reported that the surgery was delayed by fourty five minutes.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Manufacturing site evaluation: 1.Description of defect information received: io break - instrument sample product availability: yes sample product quantity: 1 piece(s) 2.Investigation 2.1 sample description we received a er402r in a decontaminated and used condition.The work end is broken.2.2 investigation used investigation method: [x] visual testing standard / specification: pictorial documentation reference no.: n/a test equipment name: vhx-5000/keyence test equipment no.: id: 42061 / 2000024840 2.3 investigation result: the investigation was carried out visually.The solder connection at the working end is broke, moreover, the shaft of the instrument is strongly deformed.A hardness test showed (specifies: 420+110 hv5 measured 486 hv5).No pores, inclusions or foreign bodies could be found on the point of rupture.It is no longer possible to understand what caused the breakage of the shank.3.Explanation, rationale, conclusion and root cause based upon the above-mentioned investigation results, a definitive root cause for the reported issue could not be established.4.Device history record results of review device history records (dhr): the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.5.Corrective measures decision for corrective measures: yes [ ] no [x] description of corrective measures incl.Recommendations to customer, if applicable: n/a 6.Sales decision plant not accepted-report only.

• Brand Name: SIMS UTERINE CURETTE #2 SHARP 255MM
• Common Device Name: SCOOPS AND CURETTES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17548923
• Report Number: 2916714-2023-00084
• Device Sequence Number: 12433441
• Product Code: HCY
• UDI-Device Identifier: 04038653042081
• UDI-Public: 4038653042081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/08/2023
• Report Date (Section F): 08/15/2023

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: ER402R
• Device Lot Number: 4513129721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2023
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/08/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/15/2023