MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS; RESECTOSCOPE SHEATH

Model Number A42011A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer.The original equipment manufacturer (oem) conducted a device history record (dhr) review for the device lot and no deviations or non-conformities during production were noted.The device was manufactured in november 2018.As a preventive measure, the instruction manual states, before use - make the product has been properly reprocessed, inspected and tested.Visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).In addition, "impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.".

Event Description

The manufacturer was informed that towards the end of a therapeutic polypectomy procedure, the device was inserted into the patient and a "pop" sound was heard.The ceramic tip at the distal end broke into pieces and fell off into the patients uterine cavity.Three device fragments were retrieved from the patient using suction techniques.In addition, dilation and curettage (d+c) was performed instead using an unspecified scraping tool which caused more bleeding.The procedure was prolonged about 30 minutes to retrieve the device fragments.A third party resectoscope was used to examine the uterine cavity; there were no other pieces visible but they are not 100% sure all device fragments were retrieved.The patient was admitted due to sleep apnea concerns which were reportedly exacerbated by the prolonged procedure.The patient is reportedly doing well.The user facility reportedly has changed their reprocessing methods for these devices to machine wash (like a dishwasher) and then steam cycle.They previously use to handwash, followed by sterad.

Manufacturer Narrative

The user facility further reported that the reported bleeding was moderate and the patient did require additional anesthesia as a result of the 30 minute delay.The patient had a longer stay, only anecdotally.To date, the suspect device has 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 device is returned for evaluation/investigation or additional significant information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

The customer returned a resection sheath (model: a42011a / lot: 18zw-0116) for the evaluation of ¿the inner sheath which is made of ceramic broke into pieces and fell off into the patients uterine cavity¿.A visual inspection was performed and confirmed that the distal end of the ceramic insulation tip was broken.There were no signs of corrosion, dents, or scratches on the resection sheath.An olympus test obturator (a22081a) was inserted into the resection sheath; the automatic locking ring on resection sheath was working properly.The customer returned a bottle filled with liquid which has the recovered broken pieces of the ceramic tip inside; however, the evaluation could not verify if all the pieces were recovered and or returned.The broken portion of the ceramic tip was producing a sharp edge.Additionally, the resection sheath was connected to an olympus test working element (wa22367a) and verified working element was engaged and locked properly.The sealing rings appeared to have no signs of damage.To mitigate the risk of damage to the device, the instructions for use manual, provides warning which states ¿impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end¿.The investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer the investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Possible causes for the reported issue are: thermo-mechanical fatigue.Improper handling due to excessive force (impact, drop, fall).Please note that signs of fatigue or pre-damage, such as minor cracks, are often hard to spot.Olympus will continue to monitor complaints for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8741029
• MDR Text Key: 149412786
• Report Number: 2951238-2019-00980
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 18ZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 07/20/2020; 03/29/2021
• Supplement Dates FDA Received: 09/24/2019; 08/05/2020; 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention