MAUDE Adverse Event Report: AESCULAP AG SIMS UTERINE CURETTE #2 SHARP 255MM; GENERAL SURGICAL INSTRUMENTS

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
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a sims uterine curette #2 sharp 255mm (material # er402r) was used during a procedure performed on (b)(6), 2023.According to the complaint description, the weld broke near the distal end at the working end and needed to be retrieved from abdominal area.Following the retrieval, the area was scanned to verify that no fragments remained inside the patient.Additional medical intervention was necessary.This event prolonged the surgery with 45 minutes.Additional information has not been made available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: the investigation was carried out visually.The solder connection at the working end is broken, 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.Device history review: 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.There are no similar complaints against the same lot number(s) with this error pattern.The current failure rate is within the risk analysis and therefore acceptable according to din en iso 14971; severity was 2(5) and probability was 1(5).Conclusion and preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.Based upon the investigation results, a capa is not required.

• Brand Name: SIMS UTERINE CURETTE #2 SHARP 255MM
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• 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: 17548919
• Report Number: 9610612-2023-00190
• Device Sequence Number: 6684280
• Product Code: HCY
• UDI-Device Identifier: 04038653042081
• UDI-Public: 4038653042081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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 Catalogue 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown