MAUDE Adverse Event Report: AESCULAP AG JAW INS.METZ SCISS.INSUL TO TIP 5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PM697R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a jaw ins.Metz sciss.Insul to tip 5/310mm (part # pm697r) was used during a procedure performed on (b)(6) 2023.According to the complainant, during the surgery, the internal component of the scissor broke off.The device fragment fell into the patient and was removed with a grasper.An x-ray was performed, which confirmed that no fragments remained inside the patient.No patient complications or surgical delays were reported as a result of this event.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.
Additional Manufacturer Narrative
Investigation results: investigator carried out the pictorial documentation visually and microscopically.The joint on one of the two scissor parts is broken and the pin connecting the two joints is missing.Device history review: based on the production date of february 2016, we were able to identify two batches for this period.This concerns the batches (b)(6).The device quality and manufacturing history records have been checked for all available 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.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The reporting decision is based upon the review of the applicable risk analysis.Conclusion/preventive measures: due to the small dimension/diameter of the device, a detailed fracture surface analysis is difficult.Due to that circumstance, there are no clear hints regarding arrest lines.Based upon the investigation results, a clear root cause conclusion cannot be determined.Based upon the investigation results, a capa is not necessary.

• Brand Name: JAW INS.METZ SCISS.INSUL TO TIP 5/310MM
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18194684
• Report Number: 2916714-2023-00123
• Device Sequence Number: 20442996
• Product Code: GEI
• UDI-Device Identifier: 04038653183555
• UDI-Public: 4038653183555
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/07/2023
• Report Date (Section F): 11/22/2023

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: PM697R
• Device Catalogue Number: PM697R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/26/2023
• Device Age: 92 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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: 11/22/2023