MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)

Model Number WA22367A

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

Patient Problem Internal Organ Perforation (1987)

Event Date 04/16/2019

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 during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the patient sustained a perforation of the bladder.The perforation occured when, during hemostasis following the biopsy, the operating surgeon retracted the hf resection electrode from the mucous membrane to remove tissue adhesions from the loop wire while output was still being emitted.No further information was provided.The intended procedure was completed with the same set of equipment.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-05-09).In addition, the outer sheath, 26 fr., 2 stopcocks, rotatable (a22026a) that was used during the procedure was sent in for investigation as well.The investigation revealed that the continuity between the hf-cable connector and the distal end is unstable.Also, the working element shows clearly visible signs of corrosion inside the ptfe/main body and the sheath is slightly damaged due to wear and tear.The unstable output from the working element is most likely caused by the corrosion inside the ptfe/main body resulting from poor/inadequate maintenance.However, this malfunction is not directly related to the adverse event reported.It is assumed that the bladder perforation was caused by unintended nerve stimulation, the potential risks of which as well as anticipated injury are clearly described in the instructions for use.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 working element 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: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Type of Device: WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8548888
• MDR Text Key: 143037573
• Report Number: 9610773-2019-00064
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (y/n): N
• PMA/PMN Number: K120418
• 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: 07/15/2019

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: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 11YW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS BIOPSY FORCEPS, SPOON TYPE (A20713A); OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-RESECTION ELECTRODE, LOOP (WA22506D); OLYMPUS INNER SHEATH, FOR 26 FR. (A22040A); OLYMPUS LIGHT-GUIDE CABLE, 2.8 MM (WA03300A); OLYMPUS OBTURATOR, DEFLECTING TIP (A22085A); OLYMPUS OUTER SHEATH, 26 FR. (A22026A); OLYMPUS OUTER SHEATH, 26 FR. (A22031A); OLYMPUS TELESCOPE, 30°, 4 MM (A22002A); OLYMPUS BIOPSY FORCEPS, SPOON TYPE (A20713A); OLYMPUS HF CABLE, BIPOLAR, 4 M (WA00014A); OLYMPUS HF-RESECTION ELECTRODE, LOOP (WA22506D); OLYMPUS INNER SHEATH, FOR 26 FR. (A22040A); OLYMPUS LIGHT-GUIDE CABLE, 2.8 MM (WA03300A); OLYMPUS OBTURATOR, DEFLECTING TIP (A22085A); OLYMPUS OUTER SHEATH, 26 FR. (A22026A); OLYMPUS OUTER SHEATH, 26 FR. (A22031A); OLYMPUS TELESCOPE, 30°, 4 MM (A22002A)
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR