MAUDE Adverse Event Report: HOLOGIC, INC. CERVICAL SEAL ASSY DEVICE; SEAL, CERVICAL, MECHANICAL, UNPOWERED

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Lot and serial number of the device not provided by the complainant, therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes, therefore, visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending, and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that on (b)(6) 2020, during a myosure procedure, after the procedure was done the surgeon removed the scope, and the tip of the omni lok remained in the cervix of the patient.The physician was able to remove the tip without additional interventions, and there were no consequences to the patient.No injuries were reported.

• Brand Name: CERVICAL SEAL ASSY DEVICE
• Type of Device: SEAL, CERVICAL, MECHANICAL, UNPOWERED
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102 ; CS 20102
• MDR Report Key: 10979042
• MDR Text Key: 220745259
• Report Number: 1222780-2020-00169
• Device Sequence Number: 1
• Product Code: QHZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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