MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., MEDIUM, 30°, WITH CABLE, STERILE; HF-ELECTRODES WITH CABLE

Model Number WA22606D

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

Patient Problem Uterine Perforation (2121)

Event Date 03/14/2019

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 hysteroscopic transurethral resection in saline (turis) procedure, the patient sustained a perforation of the uterine wall.The procedure was then converted to open surgery (laparotomy) to treat the perforation.No further information was provided, but there were no reports of any device malfunctions.

Event Description

Olympus was informed that during a hysteroscopic transurethral resection in saline (turis) procedure, the patient sustained a perforation of the uterine wall.The procedure was then converted to open surgery (laparotomy) to treat the perforation.No further information was provided, but there were no reports of any device malfunctions.The patient recovered and was discharged from the hospital.

Manufacturer Narrative

Device evaluation: the suspect medical device was not 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, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot numbers of the hf resection electrodes 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.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., MEDIUM, 30°, WITH CABLE, STERILE
• Type of Device: HF-ELECTRODES WITH CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8435604
• MDR Text Key: 139298652
• Report Number: 9610773-2019-00059
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761075470
• UDI-Public: 14042761075470
• Combination Product (y/n): N
• PMA/PMN Number: K102781
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: WA22606D
• Device Catalogue Number: WA22606D
• Device Lot Number: P1710001, P1710002, P1710007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS HF UNIT "ESG-400" (WB91051W); OLYMPUS HF UNIT "ESG-400" (WB91051W)
• Patient Outcome(s): Required Intervention