MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS CYSTOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number CYF-VHR

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2021

Event Type  Injury  

Event Description

A cystoscope was being completed and during the procedure staff noticed a black speck floating in the veteran's bladder, this was noticed at end of procedure.The surgeon believes he removed the speck with a syringe.The scope was removed and when wiping the scope a black residual/specks were noticed on 4x4 by surgical tech (st).St inspected scope prior to procedure for residual/ specks and none was found.Patient made aware of speck in his bladder, amox 500mg po x 1 post procedure per provider; 4-additional cystoscopes with noted black specks.Facility has a total 6 olympus cysto scopes ¿ model # cyf-vhr (olympus america medical systems group).These scopes get cleaned and then processed in a sterrad h202 sterilizer after each use.All six (6) scopes were returned to manufacturer -4 scopes had new bending sections installed and reglued; 2 scopes were just reglued.(b)(4).The facility will proactively send out scopes after 25 reprocessing cycles even though olympus letter notes after 100 uses.Sps and surgery techs are aware that they must inspect (we did before)---sps inspects it in decontamination room and again in the preparation (x2) and surgery is to inspect pre- and post-procedure.History of scopes: the following is sps reporting information on the cystoscopes: oer (hld) cycles on the cystoscopes (not always run through oer----this is for late cysto cases due to time, cannot run sterrad load in time per ifu): scope 7020151 ¿ run 7 times scope 7020154 ¿ run 9 times scope 7020155 ¿ run 12 times scope 7020156 ¿ run 15 times scope 7020160 ¿ run 9 times scope 7020163 ¿ run 7 times sterrad sterilization load history per scope: scope 0151 ¿ 29 cycles (13 in #5, 16 in #6) scope 0154 ¿ 30 cycles (16 in #5, 14 in #6) scope 0155 ¿ 37 cycles (17 in #5, 20 in #6) scope 156 ¿ 31 cycles (13 in #5, 18 in #6) scope 160 ¿ 25 cycles (11 in #5, 14 in #6) scope 163 ¿ 32 cycles (14 in #5, 18 in #6) chemicals used within sps on these products: sterrad -- msds 09461-0-001 hydrogen peroxide solution intercept detergent (medivator) ¿ msds 68391-01-5 endoquick (when going through oer) acecide-c (when going through oer) 70% isopropyl rubbing alcohol.Fda safety report id # (b)(4).

• Brand Name: OLYMPUS CYSTOSCOPE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 11744398
• MDR Text Key: 248176252
• Report Number: MW5101053
• Device Sequence Number: 2
• Product Code: NWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-VHR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR