MAUDE Adverse Event Report: HOLOGIC, INC DEFINITY CERVICAL DILATOR

Model Number DCD-705

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The device was received and evaluated for the reported complaint.There were no visual defects noted and the device passed mechanical testing.The reported complaint could not be confirmed.This observation will be monitored and trended.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.

Event Description

It was reported that during the procedure, the device was inserted to dilate the patient.There were no issues with dilating.A scope was inserted to the patient and a small perforation at the fundus was found in which you could see the bowel through.No additional details available at this time.

• Brand Name: DEFINITY CERVICAL DILATOR
• Type of Device: CERVICAL DILATOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, ma ; 2636130
• MDR Report Key: 9872079
• MDR Text Key: 185658883
• Report Number: 1222780-2020-00064
• Device Sequence Number: 1
• Product Code: PON
• UDI-Device Identifier: 35420045512454
• UDI-Public: (01)35420045512454(10)20A16RC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2002
• Device Model Number: DCD-705
• Device Catalogue Number: DCD-705
• Device Lot Number: 20A16RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other