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 05/29/2020

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 therapeutical transurethral resection in saline (turis) procedure, the patient sustained a perforation of the bladder.The intended procedure was initially completed with the same set of equipment.Then, the next day, a follow-up laparotomy procedure was performed to treat the perforation.No further information was provided, but there was no report of a malfunction of the olympus medical devices.Furthermore, it is assumed that a nerve reflex is causal for the perforation of the bladder because no nerve block anesthesia was performed.

Manufacturer Narrative

Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The working element shows minor discoloration on the internal contact due to heat development and, when examined in conjunction with a test electrode, it shows an increased resistance.Thus, the instrument does not meet the electrical testing standard.However, there cannot be a direct causal relationship between this failure and the reported incident.On the basis of the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, based on the event description, the perforation of the bladder was most likely caused by nerve reflexes possibly due to inadequate nerve block anesthesia.Also, the nerve stimulation may have been caused by fluctuations in the current frequency due to a suboptimal contact between the working element and the electrode.Or, the nerve stimulation may have occurred as a result of the surgeon¿s attempt to clean the electrode from adhering deposits within the bladder, which should be done outside the body with bipolar electrodes.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf electrode without showing any abnormalities.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• 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: 10193639
• MDR Text Key: 196608668
• Report Number: 9610773-2020-00143
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 183W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS BIOPSY FORCEPS (A20713A); OLYMPUS GRASPING FORCEPS (A20718A); OLYMPUS HF CABLE, BIPOLAR (WA00014A); OLYMPUS HF UNIT "ESG-400" (WB91051J); OLYMPUS HF-RESECTION ELECTRODE (WA22351C); OLYMPUS HF-RESECTION ELECTRODE (WA22355C); OLYMPUS HF-RESECTION ELECTRODE (WA22507D); OLYMPUS INNER SHEATH (A22040A); OLYMPUS INSTRUMENT TRAY (WA05970A); OLYMPUS LIGHT-GUIDE CABLE (WA03300A); OLYMPUS OBTURATOR (A22086A); OLYMPUS OUTER SHEATH (A22026A); OLYMPUS TELESCOPE, 30°, 4 MM (A22002A)
• Patient Outcome(s): Required Intervention