MAUDE Adverse Event Report: AESCULAP AG TC MAYO SCISSORS CVD 170MM; BASIC INSTRUMENTS

Model Number BC253R

Device Problem Fracture (1260)

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

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with bc253r - tc mayo scissors cvd 170mm.According to the complaint description, the device broke.The scrub nurse had noted a piece of metal had fallen into the surgical field.Upon inspection of the instrument, the scissor was found to be broken.An additional medical intervention was required.The piece was retrieved.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information /investigation results will be provided in a supplemental report.

Manufacturer Narrative

Investigation: visual investigation: the scissors are in a used condition.A piece of the carbide insert has broken off from one cutting edge - the fragment is available for examination.There are corrosion spots on the surface, most likely caused by reprocessing.The analysis of the fracture pattern showed 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 an impact that caused the piece to break.During cutting, the fragment was then finally broken out completely.This is also supported by the fact that no damage or other traces can be found on the counter blade.Likewise, a crack of the cutting edge was found 5mm next to the gap in the direction of the tip of the scissors.This should be in the same context.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaints aginst the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: 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 shipped in this condition because they do neet meet aag standards, the cause is most likely handling.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 investigation results a capa is not necessary.

• Brand Name: TC MAYO SCISSORS CVD 170MM
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15174822
• MDR Text Key: 297331852
• Report Number: 9610612-2022-00170
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC253R
• Device Catalogue Number: BC253R
• Device Lot Number: 4512876567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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