MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. HULKA CLIPS; TUBAL OCCLUDING DEVICE IN A STERILE POUCH

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Rwmic considers this mdr/complaint open.A follow up report will be submitted once additional information are available.

Event Description

On (b)(6) 2020 the patient contacted rwmic and the following was reported: customer stated that she was one of the patients that had a hulka clip inserted on (b)(6)1990 and insisted that doctors should do allergy tests prior to a procedure.She also stated that in 1994, she underwent isotopic radiation at sunnybrook which according to her caused the plastic to melt and fuse the clips to her intestines.The metal toxicity affected her body and for the past 27 years she's been disabled.Will the device be returned? no.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? no.Did the delay put the patient at risk? (only applicable if there was a report of delay) no.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? n/a.

Event Description

Follow-up report #1 is to provide fda with changed/ corrected information.

Manufacturer Narrative

Follow-up report #1 is to provide fda with corrected information.Upon review of the complaint file, it was noticed that the initial reporter had provided all the current available information.Therefore no new/additional information could be obtain at this time.Since the device will not be returned for evaluation and additional information could not be provided, rwmic considers this complaint and mdr closed.However, in the event that new information become available, a follow up report will be submitted.

Manufacturer Narrative

This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with new information.New information: the following fields have new information: h10.Because the device is implanted, it is practically impossible for the device to be returned and for that reason, we are unable to evaluate the device instead, a product history evaluation for hulka clip (4986.09, 4986.90, 4986.05) was completed.The hulka clip is an implantable device manufactured by richard wolf medical instrument corporation (rwmic).Between 2019 to the present, rwmic received a number of complaints from patients alleging problems with the hulka clip.See attached spreadsheet for complaints received from 2019 to the present.As part of the due diligence, the patients were asked to confirm with their medical provider that 1.The device they had implanted was, in fact, a hulka clip.2.The part number and lot/batch number of the device.To date, for the attached complaints, this information was not provided to rwmic.For that reason, rwmic is unable to verify whether or not the device implanted is the rwmic hulka clip.The associated patient information guide (e36e-11-03) and letter to physicians included with the hulka clip gives the potential risk to the patient.Potential risks: the most serious known potential adverse effect is ectopic pregnancy.Other adverse effects are pregnancy, abnormal menstrual patterns, infection, pain and trauma (bleeding).There is a minimal risk that the body might be allergic to such materials as metal or plastic, causing an infection or adhesion.As with any surgical procedure, surgical errors are possible and could include misapplication of the clip, and cutting of unintended tissue or organs.Other unusual risks, including fatality, are always possible, but are as rare as with any common operation.The procedure is not recommended for all women who don't want more children.Sometimes previous surgery, being overweight, or other medical problems may mean that another solution to her problem should be worked out.There will be no change in your normal hormone function or ministration since the ovaries are not damaged.Because the device is implanted, it is practically impossible for the device to be returned and for that reason, we are unable to evaluate the device.This memo replaces the product investigation report (5020) and/or the product history evaluation (5253).Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the product history evaluation.See manufacturers narrative (h10).

• Brand Name: HULKA CLIPS
• Type of Device: TUBAL OCCLUDING DEVICE IN A STERILE POUCH
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: hersi kotori ; 353 corporate woods parkway; vernon hills, IL 60061 ; 8479131113
• MDR Report Key: 10756099
• MDR Text Key: 213696584
• Report Number: 1418479-2020-00036
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• 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
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Sex: Female