MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OBTURATOR, DEFLECTING TIP, 28 FR.; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A22087A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been received by olympus for evaluation (although it is anticipated).The definitive cause of the users experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a transurethral resection of the prostate (turp) using a wa22067a passive working element, an a22043a 28fr resection sheath, an a0393 monopolar high frequency (hf) cable, an a22087a 28fr deflecting tip obturator, and an a22052a rotatable luer-lock irrigation port, the grounding pad was not placed properly on the patients leg and the patient experienced a serious burn.The burn occurred during the procedure as the urologist activated the electrode to resect prostate tissue.The procedure was cancelled due to the burn.It is not known what intervention was required to treat the burn.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.(b)(6) reports the wa22067a.(b)(6) reports the a0393.(b)(6) reports the a22087a.(b)(6) reports the a22052a.(b)(6) reports the a22043a.

Manufacturer Narrative

This report is being updated to provide additional information and corrected information.

Event Description

Update: the customer clarified 02jul2021 that the customer does not use an olympus generator or olympus grounding pads.The burn experienced by the patient is not related to the use of an olympus device.

• Brand Name: OBTURATOR, DEFLECTING TIP, 28 FR.
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12063808
• MDR Text Key: 266671688
• Report Number: 9610773-2021-00173
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761021203
• UDI-Public: 04042761021203
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A22087A
• Device Catalogue Number: A22087A
• Device Lot Number: 12YW-0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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
• Patient Outcome(s): Other