MAUDE Adverse Event Report: AESCULAP AG TC IRIS SCISSORS CVD S/S 110MM; DUROTIP SCISSORS

Model Number	BC211R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a tc iris scissors cvd s/s 110mm (part # bc211r) was used during an unspecified procedure on (b)(6) 2024.According to the complainant tip of instrument broke inside the patient.Reportedly there was an unspecified delay to the surgery due to the time it took to retrieve the broken piece.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
It was reported to aesculap inc.That a tc iris scissors cvd s/s 110mm (part # bc211r) was used during an unspecifiedprocedure on (b)(6) 2024.According to the complainant tip of instrument broke inside the patient.Reportedly there was an unspecified delay to the surgery due to the time it took to retrieve the broken piece.No patient complications were reported as a result of this event.· was the broken piece removed from the patient? yes and given to the spd team.· what type of medical intervention(s) was required? none patient did not require any treatment as the piece was easily visualized and removed.· what was the outcome and patient status after the procedure? stable and as expected discharged without incident.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Additional information provided: b5 - no patient complications f9 - age of device.Investigation results: one (1) sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually that the tip of the scissors was fractured.The analysis of the fracture pattern showed signs of a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Therefore, a material or production related failure can be excluded.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Based on the investigation findings, the cause of the fracture was unable to be determined.As a result, the reported failure could not be confirmed to be a manufacturing related issue.There are no similar complaints against the reported lot number with this error pattern.

• Brand Name: TC IRIS SCISSORS CVD S/S 110MM
• Common Device Name: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 19086572
• Report Number: 2916714-2024-00071
• Device Sequence Number: 7819822
• Product Code: LRW
• UDI-Device Identifier: 04038653137664
• UDI-Public: 4038653137664
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/28/2024
• Report Date (Section F): 04/11/2024

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: BC211R
• Device Catalogue Number: BC211R
• Device Lot Number: 4506970527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/22/2024
• Device Age: 105 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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: 04/11/2024