MAUDE Adverse Event Report: HOLOGIC, INC. TOMCAT INSTRUMENT; SAMPLE TRANSFER SYSTEM

Catalog Number ASY-07379

Device Problem Difficult to Open or Close (2921)

Patient Problems Disability (2371); Patient Problem/Medical Problem (2688)

Event Date 08/23/2018

Event Type  Injury  

Event Description

A customer complained that after their thinprep vials were finished processing by the tomcat instrument, the returned vials were recapped too tight.This caused their cytologists to experience pain in their wrists when uncapping the vials.One cytotech has asked for medical attention and been diagnosed with carpal tunnel syndrome that could be attributed with uncapping these vials.Per risk assessment, the severity of this risk is serious where tightly capped thinprep vials could have resulted in a customer seeking medical intervention and being diagnosed with carpal tunnel syndrome.However, the probability of harm is remote as being diagnosed with carpal tunnel syndrome while just uncapping thinprep vials is unlikely but possible to occur over the lifetime of the product.Further investigation into this issue is ongoing.

Event Description

This is a follow-up and final report for mfr report # 2024800-2018-00010.Hologic performed an investigation.Prior to processing on the tomcat, the thinprep vials contain marker lines between the bottle and the cap that align.The customer's returned vials after processing on the tomcat show the cap alignment marker was positioned past the manufacture's bottle alignment marker.An assessment of internal tomcat post processing vials showed that the cap alignment markers were also positioned past the marker line confirming the customer vials were recapped as expected.Hologic tested 13 thinprep vials returned from the customer along with 25 new thinprep vials processed on an internal tomcat instrument to record the uncapping torque.The measured uncapping torque of the customer's samples averaged 23 in-lbs and the uncapping of the internal tomcat averaged 24 in-lbs.This indicated the customer's tomcat instrument is not over tightening the caps and is performing similarly to hologic's internal instruments that were used as a reference.The tomcat instrument specification for the recapping torque of thinprep vials is defined between 15 to 20 in-lbs.Manual recapping of new vials to within instrument specifications (15-20 in-lbs) shows that the required uncapping torque is on average higher than the instrument processed vials.This is an indication that the instrument in not over tightening the caps.In all the customer's tomcat instrument appears to be within design specification of the recapping torque.

• Brand Name: TOMCAT INSTRUMENT
• Type of Device: SAMPLE TRANSFER SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center dr; san diego CA 92121
• MDR Report Key: 7887349
• MDR Text Key: 120693629
• Report Number: 2024800-2018-00010
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 15420045504677
• UDI-Public: 15420045504677
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ASY-07379
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other