MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS CVD 180MM; BASIC INSTRUMENTS

Model Number BC263R

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  Injury  

Event Description

It was reported to aesculap ag that a tc metzenbaum scissors cvd 180mm (part # bc263r) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the tip of the device broke off.An x-ray screening was performed to determine if the fragment detached into the patient, but nothing was found.The complaint device has been returned to the manufacturer for evaluation.An additional medical intervention was required.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information/ correction: b6 - added relevant test.D9 - date of the product receipt.E1 - added end customer telephone number.H3 - device evaluated.H6 - codes updated.Investigation results: visual investigation: product was made available for investigation in decontaminated condition.The scissors are in a used condition.The end of the tip of the blade has broken off, the broken fragment is not available for examination.There are deposits on the surface that were most likely caused by reprocessing.The analysis of the fracture pattern revealed a forced fracture due to overload.No pores, inclusions or foreign bodies could be found at the fracture site.The fracture was most likely caused by levering or unsuitable material was processed with the scissors, which caused the tip to break.This is also supported by the fact that counter blade shows damage and pressure marks at the same height.This is likely to be in the same context.In order to obtain a more accurate examination result, the broken-off piece should also be provided for examination.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard, a material defect and a production defect can most likely be ruled out.There are no indications of previous damage or similar.We can rule out a manufacturing-related cause based on current analysis results.It is almost certain that a mechanical overload situation led to the breakage.Instruments with carbide inserts are sensitive to lateral loads such as torsional and lever forces or impacts.Since these scissors were not delivered in this condition because they do not comply with the aag standard, the cause can in all probability be found in the handling, but this cannot be clearly proven.The reason for the deviation cannot be determined.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.Based upon the investigations results a capa is not necessary.

Event Description

The adverse event is filed under aag reference: (b)(4).

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Type of Device: BASIC 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 grun ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15693765
• MDR Text Key: 302678318
• Report Number: 9610612-2022-00303
• Device Sequence Number: 1
• Product Code: LRW
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC263R
• Device Catalogue Number: BC263R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention