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

Model Number BC111R

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with bc111r - iris scissors cvd s/s 110mm.According to the complaint description, the scissors broke inside patients nose during surgery.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.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

Additional information: d4 - batch number.D9 - product return date.H4 - production date.H6 - codes updated.Investigation: visual investigation: here we found one tip broken off.The fracture surface shows a corroded area, which could indicate an initial crack.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) 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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: the corroded area could indicate an initial crack.This could have been caused by a mechanical overload.The corrosion that took place in the crack was ultimately conducive to the fracture at last.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 defect or manufacturing failure on the basis of the device history records.Based on the investigation results, a capa is not necessary.

• Brand Name: IRIS SCISSORS CVD S/S 110MM
• Type of Device: SURGICAL SCISSORS
• 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: 13977859
• MDR Text Key: 288621075
• Report Number: 9610612-2022-00094
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC111R
• Device Catalogue Number: BC111R
• Device Lot Number: 4512304698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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