MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22041A

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Olympus was informed that during a combined diagnostic hysteroscopy and transcervical resection of the endometrium in saline (tcris) procedure, the ceramic insulation at the distal end of the resection sheath a22041a broke off and fell inside the patient's uterus.Furthermore, the loop wire at the distal end of the hf resection electrode wa22306d broke off as well.While the ceramic insulation was retrieved from the patient by unknown approach, the loop wire remained inside the endometrium since it could not be located by ultrasound.No further information was provided and it is unknown if and how the intended procedure was completed.However, there was no adverse event or patient injury.This is report 2 out of 2.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.However, based on the customer description, the damage of the insulation was caused by thermal mechanical force.It is very likely that a vertical crack occurred before the insulation part broke off.The instructions for use include information on how to check and test the sheath before every usage.Damaged items must not be used as they can pose a risk for the patient, user or a third person.The item cannot be used anymore.The root cause can be tracked down to thermal mechanical force in combination with wear and tear.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6412522
• MDR Text Key: 70453937
• Report Number: 9610773-2017-00044
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Other Device ID Number: 04042761020961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HF UNIT "ESG-400" (WB91051W); TCRIS HYSTEROSCOPE
• Patient Age: 74 YR