MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22040A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus 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 device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic procedure the ceramic insulation at the distal end of the inner sheath broke off and fell into the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but the intended procedure was completed using a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2020-10-29).The investigation confirmed that two fragments of the ceramic insulation at the distal end of the inner sheath had broken out.However, no part was missing since the complete fragment was returned as well.Although it cannot be determined with certainty whether the inner sheath had been previously damaged during reprocessing without parts breaking off immediately or whether the damage occurred during the procedure, the cause of this damage is most likely thermal and/or mechanical overload by the application of excessive force like impact, fall, shock or similar stress.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the inner sheath without showing any abnormalities.The case will be closed from olympus side but, independently from the above mentioned issue, a capa was initiated in march 2019 where further investigations, trending, and surveillance will be performed.Furthermore, the user will be informed about the investigation results.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10761688
• MDR Text Key: 224966190
• Report Number: 9610773-2020-00251
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• 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: 11/24/2020

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 20302
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1