MAUDE Adverse Event Report: AESCULAP AG VALVE XS DISS.SCISSORS 15°CVD.235/370MM; SPECIALITIES CARDIO-THORACIC S

Model Number FC265R

Device Problems Mechanical Problem (1384); Failure to Align (2522); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.

Event Description

It was reported the scissors malfunctioned intraoperatively.During a minimally invasive coronary artery bypass graft (cabg) procedure, while using a pair of scissors the blades started crossing too far and would get stuck.Per the reporter, both blades fall to the side occasionally as you operate the scissors.A second parif of scissors were used, which demonstrated the same issue.The surgery was reported to have taken a little longer due to obtaining a third pair of scissors from a different company to finish the case.No harm was done to the patient.No other information has been provided.Associated medwatches: 9610612-2019-00176.

Manufacturer Narrative

Associated medwatches: 9610612-2019-00175 and 9610612-2019-00176.Manufacturing site evaluation: the products were provided decontaminated and been forwarded to the manufacturer for investigation.Failure description: the mechanics of the blades of both pairs of scissors are no longer working according to specifications.The blades cross each other, the limitation stop is not in place.No other deviations can be found.Investigation: during the function test, the blades crossed each other since the limitations stops were broken; the fragments were not available for investigation.The microscopic inspection of the fracture pattern illustrated a shear fracture due to overload.The manufacturer, dausch medizintechnik gmbh carried out further investigations.According to their report, the breakage of the mechanics was caused by an overload situation due to cutting too much and /or hard tissue with high pressure.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Conclusions and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most likely related to an insufficient usage.Rationale: according to the investigation report from the manufacturer, the reason for the failure was due to an overload situation, for example trying to cut hard tissue with too much force.

• Brand Name: VALVE XS DISS.SCISSORS 15°CVD.235/370MM
• Type of Device: SPECIALITIES CARDIO-THORACIC S
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8418792
• MDR Text Key: 138776330
• Report Number: 9610612-2019-00175
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC265R
• Device Catalogue Number: FC265R
• Device Lot Number: 52322113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Distributor Facility Aware Date: 05/09/2019
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 06/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1