MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE; OUTER SHEATHS

Catalog Number A22021A

Device Problem Break (1069)

Patient Problem Twitching (2172)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified transurethral resection (tur) procedure, the ceramic insulation of the resection sheath (a22041a) broke off inside the pt.No fragments/parts remained inside the ot as they were reportedly retrieved by unk approach.The intended procedure was reportedly completed by using a similar device.There was no report about an adverse event or pt harm or injury.However, it was reported that the pt's legs were repeatedly twitching due to the unintended stimulation of the obturator nerve.Furthermore, an identical product problem/malfunction reportedly occurred again with a resection sheath of the same model (a22041a) but from a different lot during another subsequent procedure.However, no other info was provided for the second incident.

Manufacturer Narrative

The suspected 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 and is being judged as unk.However, if the suspect medical devices are returned for eval or add'l significant info becomes available, this report will be updated.This report refers to the suspect medical device labeled as a22021a in the initial report about the same incident.Cross-reference to/duplicate of mfr report # 9610773-2014-00016, 9610773-2014-00017, 9610773-2014-00019.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE
• Type of Device: OUTER SHEATHS
• 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: 3884149
• MDR Text Key: 4542205
• Report Number: 9610773-2014-00018
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A22021A
• Device Lot Number: 36W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2003
• 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: WORKING ELEMENT, ACTIVE (A22060A); RESECTION SHEATH, 24 FR. (A22041A); HF-RESECTION ELECTRODE, BAND, 24 FR. (A22221C)
• Patient Outcome(s): Other