MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22021A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation / investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation / investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that after a therapeutic transurethral resection in saline (turis) procedure on (b)(6) 2019, the patient still was not able to properly void.Therefore, a second turis procedure was performed on (b)(6) 2019.During this procedure, the patient sustained a burn injury on the top of his penis which required appropriate treatment.However, none of the olympus medical devices used during the procedure showed any malfunction.In addition, the intended procedure was reportedly completed with the same set of equipment.

Manufacturer Narrative

Device evaluation: the suspect medical device as well as the listed concomitant devices were returned to the manufacturer for evaluation/investigation.During the investigation the following observations were made: the tube of the outer sheath (a22021a) does not show any significant external damage, but the inflow stopcock is defective and the laser marking is worn out.The electrical function and safety of the working elements (wa22366a and wa22367a) comply with the specifications.However, wa22366a shows significant corrosion at the proximal end.Despite minor signs of use, the obturator (a22081a), the working element (wa22367a) and the resection sheath (a22041a) meet all applicable standards and specifications.In addition, a visual and functional inspection of the cables (wa00014a) was performed without revealing any deviations.The cause of this damage is most likely incorrect reprocessing and improper handling.However, the components do not show any malfunction or damage, which could have contributed to the reported incident.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the outer sheath as well as all listed concomitant devices without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9134023
• MDR Text Key: 161188512
• Report Number: 9610773-2019-00129
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A22021A
• Device Catalogue Number: A22021A
• Device Lot Number: 126W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF CABLE, BIPOLAR (WA00014A); OLYMPUS HF-RESECTION ELECTRODE, LOOP (WA22302D); OLYMPUS HF-RESECTION ELECTRODE, LOOP (WA22306D); OLYMPUS OBTURATOR, 24 FR. (A22081A); OLYMPUS RESECTION SHEATH, 24 FR. (A22041A); OLYMPUS WORKING ELEMENT, ACTIVE (WA22366A); OLYMPUS WORKING ELEMENT, PASSIVE (WA22367A)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR