MAUDE Adverse Event Report: MORCHER STUTTGART GMBH REFORM CAPSULAR TENSION RING; RING, ENDOCAPSULAR

Model Number ACTR11

Device Problem Defective Device (2588)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

A healthcare professional reported that during ctr ring implantation the loops on the end was broken.The surgeon had to take out the broken part and use a different ring.The surgery was completed during the initial procedure.There was no patient harm.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

The review of the device history record (dhr)of company showed no irregularities or deviations.All released rings met their dimensions according to the review of the measurement protocols.A product examination could not be made due to the product was not returned.The ifu (instructions for use) and risk analysis were considered acceptable.Hygienic condition of the product was unknown, the product was not returned.A manufacture-related root cause is not detectable.User-related factors, such as handling or loading techniques of the actr might have contributed to the event.The manufacturer internal reference number is: (b)(4).

• Brand Name: REFORM CAPSULAR TENSION RING
• Type of Device: RING, ENDOCAPSULAR
• Manufacturer (Section D): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer (Section G): MORCHER STUTTGART GMBH; kapuzinerweg 12; stuttgart 70374 ; GM 70374
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18344276
• MDR Text Key: 331064150
• Report Number: 1610287-2023-00050
• Device Sequence Number: 1
• Product Code: MRJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACTR11
• Device Catalogue Number: ACTR11
• Device Lot Number: CCJCDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SINKSY AND CTR INSERTER.
• Patient Age: 70 YR
• Patient Sex: Male