MAUDE Adverse Event Report: HOLOGIC, INC. OMNI LOCK CERVICAL SEAL; SEAL, CERVICAL, MECHANICAL, UNPOWERED

Model Number	OLK-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that on (b)(6) 2020, during a procedure the tip of the omnilok came off and was difficult to remove from the cervix.No patient injury was reported.No impact to the patient.

• Brand Name: OMNI LOCK CERVICAL SEAL
• Common Device Name: SEAL, CERVICAL, MECHANICAL, UNPOWERED
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11280725
• Report Number: 1222780-2021-00019
• Device Sequence Number: 17176872
• Product Code: QHZ
• UDI-Device Identifier: 15420045512191
• UDI-Public: (01)15420045512191(17)221128(10)19L29RF
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: OLK-100
• Device Catalogue Number: OLK-100
• Device Lot Number: 19L29RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other