MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE; HF-RESECTION ELECTRODES

Catalog Number WA22302D

Device Problems Break (1069); Component Falling (1105); Melted (1385); Sparking (2595)

Patient Problem No Information (3190)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

Olmypus was informed that during an unspecified hysteromyomectomy procedure, the loop wire of the suspect medical device sparked, melted, broke off and fell inside the pt's uterus.Subsequently, an identical product problem/malfunction occurred again with a second hr resection electrode from the same model.However, here no fragment/part broke off and fell inside the pt as they were reportedly retrieved by unspecified surgical instrument.The intended procedure was finally completed by using a third hf resection electrode and there was no report about an adverse event or pt injury.

Manufacturer Narrative

The suspect medical devices were not yet returned to the mfr for eval/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined adn is being judged as unk.However, if the suspect medical devices are returned for eval/investigation or add'l significant info becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 4216924
• MDR Text Key: 16987833
• Report Number: 9610773-2014-00048
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WA22302D
• Device Lot Number: 13289P01L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NUMBER: (B)(4)); OLYMPUS UES-40 ELECTROSURGICAL GENERATOR (SERIAL
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 65