MAUDE Adverse Event Report: RICHARD WOLF GMBH NASAL SCISSORS

Model Number 8211.221

Device Problem Break (1069)

Patient Problems Cerebrospinal Fluid Leakage (1772); Foreign Body In Patient (2687)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

Actual device sent to manufacturer on 16mar2016.Investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).

Event Description

(b)(4).Facility reported one of the scissor tines broke off inside of patients nasal cavity during procedure.An x-ray and an ent surgeon was required to removed foreign object.In addition, patient was transferred to a higher level of care due to additional surgery and prolonged operating time.

Manufacturer Narrative

Investigation report completed 05/13/2016.Cause of the break appears to be material fatigue due to normal wear and tear, device is over 15 years old.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Rw (b)(4) considers this matter closed.However, in the event additional information is received, rw (b)(4) will provide fda with follow-up information.(b)(4).

Event Description

Device was labeled such that it indicated it was last repaired in 1988.Hardness test was performed on device and passed current specifications.

Event Description

Follow up #2.

Manufacturer Narrative

Follow up #2.Rwgmbh received a voluntary event report (mw507475) on 16feb2018 that was completed by the patient.Rwgmbh considers this report closed.If any additional information regarding this event is received, a follow up report will be sent to the fda.Richard wolf medical instruments corporation (rwmic) (importer) submitting report on behalf of richard wolf (rwgmbh) (manufacturer).

Event Description

Follow-up #3 06-21-2018.Medwatch report mw (b)(4) was sent to rwmic from fda, information received on 06/01/2018.Details of the medwatch report are below and are also attached, see section h10.Hospital had made it unavailable to us.I went in for exploratory cerebral sinus fluid leak surgery at 6pm on monday, (b)(6) 2015.During the surgery the surgeon saw a thin csf pulsation in the upper left nasal area.He went to make a patch from thin tissue in the lining of the right nostril.As he went to cut the soft tissue from the right nostril, the tip of the curved nasal scissor broke off and fell.They did immediate x-rays of the stomach and lungs, not knowing where the scissor tips had fallen.They eventually found the tip behind my adenoids and called in another surgeon.They head-locked me and the new surgeon put his hands in and up my throat, using tools as well, to try to retrieve the scissor tip fragment.It took hrs for them to retrieve the scissor tips, head-locking and whiplashing my head and neck.I came out of the surgery around 11:30pm, intubated because of the surgeon's worries my throat would swell shut from the trauma.I was manually bagged down the hall into my icu room, where i stayed intubated until late morning on (b)(6) 2015.I woke up with extreme facial pain and a headache, not even touchable with medicine.They left me in icu until late wednesday, (b)(6) 2015, them moved me to the post-neurosurgery special care unit for another 48 hrs.They discharged me friday, (b) (6) 2015.From the moment the tips of the scissors broke off during surgery, around 7:45p monday (b) (6) 2015 until my discharge, friday (b) (6) 2015, (b) (6) covered my hospital costs.To this day i continue to have neck pain and a chronic headache, as well as facial numbing in certain areas and neurological issues, due to this surgery.I have not been well since i woke up on (b) (6) 2015.Concomitant medical: diclofenac, hizentra, neurostimulator.Initial reporter information: (b)(6).Occupation: patient.Email: (b)(6).Phone: (b)(6).

Manufacturer Narrative

Follow-up #3, the following sections were updated: medwatch mw (b)(4) is attached.If any additional information regarding this event is received, a follow-up report will be sent to the fda.Richard wolf medical instruments corporation (rwmic) (importer) is submitting this report on behalf of richard wolf (rw gmbh) (manufacturer).- attachment: [medwatch (b)(4).Pdf].

• Brand Name: NASAL SCISSORS
• Type of Device: NASAL SCISSORS
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 5502902
• MDR Text Key: 40662403
• Report Number: 9611102-2016-00004
• Device Sequence Number: 1
• Product Code: KBD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2016,06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8211.221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 03/16/2016
• Distributor Facility Aware Date: 02/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2016
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROBIOTIC; SINGULAIR; VYFELMA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 88