MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING INSERT, ALBARRAN, TWO WAY; WORKING INSERTS WITH ALBARAN LEVER

Model Number A20972A

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome 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.Please note: as of today the customer did not provide the model number for the effected device.Therefore, we entered a probable number.

Event Description

Olympus was informed that during an unspecified therapeutic procedure the albarran perforated the patient's urethra causing a tear in several places of the urothelium.The albarran was twisted 90 degrees.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, based on the information provided, the cause for the patient injury is very likely improper handling by the customer.It is assumed that the user removed the working insert (with the erect albarran) out of the patient¿s body together with the sheath and the optical instrument, instead of pulling it out through the sheath, which serves as place holder in the patient¿s body.A dhr review could not be performed since basic data of article identification (lot number) are missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.Please note: as of today the customer did not provide the model number for the effected device.Therefore, we entered a probable model number.

Manufacturer Narrative

Additional information: d4 ¿ lot number; h4 ¿ device manufacturer date the suspect medical device was returned to olympus for evaluation/investigation.During the investigation both the pull wires and the albarran lever were found to be missing.Furthermore, the distal end of the telescope channel is severely deformed and shows visible tool marks.The proximal end of the telescope channel shows dents and further deformations and it is no longer possible to insert a telescope.It is very unlikely that this severe damage occurred during use, rather it is assumed that it was caused afterwards by improper handling by the customer.Based on the information provided, it is assumed that the albarran and its pull wires were deformed due to mechanical overload.The cause for the reported patient injury is very likely improper handling by the customer.It is assumed that the user removed the working insert (with the erect albarran) out of the patient¿s body together with the sheath and the optical instrument, instead of pulling it out through the sheath, which serves as place holder in the patient¿s body.A manufacturing and quality control review was performed for the affected lot number of the working insert without showing any abnormalities.The case will be closed from olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: WORKING INSERT, ALBARRAN, TWO WAY
• Type of Device: WORKING INSERTS WITH ALBARAN LEVER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 12317746
• MDR Text Key: 266369006
• Report Number: 9610773-2021-00226
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761020374
• UDI-Public: 04042761020374
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A20972A
• Device Catalogue Number: A20972A
• Device Lot Number: 19703-0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention