MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-611L

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under mdr # 2951238-2021-00425.

Event Description

The study involved patients with ulcerative colitis who had a restorative proctocolectomy treated with an ileal pouch to anal anastomosis (ipaa) surgery.Pouch stricture is a common complication in such patients.This study performed stricturotomy or balloon dilation to treat the pouch strictures (and afferent limb strictures).The patients were treated between 2008 through 2017.There were 40 patients treated with the stricturotomy and 160 patients treated with an endoscopic balloon dilation.The authors stated the strictures were treated with either a non-olympus needle knife or an olympus single use electrosurgical it knife2.Per the authors, strictures were incised circumferentially or radially until the adequate passage of the scope was achieved.The authors also stated the patients who received the stricturotomy were significantly older than the other group and the duration from the stricture diagnosis to the treatment was also longer in the stricturotomy group.The patients reported to have perforations were in the endoscopic balloon dilation group and an olympus device was not used.Stricturotomy group only, serious adverse events: 7 patients had post-procedural bleeding, 3 patients with procedure-related delayed bleeding requiring a transfusion.

Manufacturer Narrative

This supplemental report is being submitted to include a correction for the 7 patients with bleeding that did not require intervention and not reportable.

Event Description

Additional information received from the author: this is complaint 1 of 2 for patient identifier (b)(6) for the serious adverse events.Stricturotomy group only, 3 patients with procedure-related delayed bleeding requiring a transfusion.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12578537
• MDR Text Key: 275239918
• Report Number: 8010047-2021-12737
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-611L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other