MAUDE Adverse Event Report: CATHETER RESEARCH, INC. UTERINE MANIPULATOR & INJECTOR (PUMI) 4.5MM; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number TH3111

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured in november 2015 as part of a lot size of 1224.It is the first unit reported from that lot.The th3111 is part of a family of uterine manipulators.Since (b)(4) 2015, catheter research has manufactured and sold approximately (b)(4) units and has reported breakage of a total of 6, including the unit in this report, to fda.Manufacture dates of the units that experienced the breakage: (b)(4) 2015, (b)(4) 2015, (b)(4) 2016, (b)(4) 2016, (b)(4) 2016, (b)(4) 2017.There does not appear to be any pattern to the manufacturing dates.The "serious injury" for some of these events has been the requirement to remove the device after the procedure.The ifu instructs the user to check for broken pieces before finishing the procedure.In this case, the user appears to have followed the ifu, but reported the breakage to local regulatory authorities.

Event Description

(b)(6) received the following uf report from its direct customer, purple surgical, the initial reporter described later.The (b)(6) hospital in (b)(6) reported this issue with the uterine manipulator, th3111 : describe the fault with the product device broke into two parts during use in a laparoscopic gynae procedure.Inflated balloon was left inside the patient which was safely retrieved by consultant gynae surgeon what procedure was being carried out? lap gynae procedure.Was there any patient harm? no injury caused.(b)(6) comment - although no injury occurred with this incident, other incidents of breakage have resulted in a requirement for medical intervention to remove broken pieces, constituting "serious injury.".

• Brand Name: UTERINE MANIPULATOR & INJECTOR (PUMI) 4.5MM
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CATHETER RESEARCH, INC.; 6102 victory way; indianapolis IN 46278
• Manufacturer (Section G): CATHETER RESEARCH, INC.; 6102 victory way; indianapolis IN 46278
• Manufacturer Contact: john browder ; 6102 victory way; indianapolis, IN 46278 ; 3178603565
• MDR Report Key: 7042541
• MDR Text Key: 93058250
• Report Number: 1833117-2017-00007
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: TH3111
• Device Catalogue Number: TH3111
• Device Lot Number: M954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• 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