MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858); Bowel Perforation (2668)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information.Doi: 10.1111/den.14639.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

Olympus reviewed the following literature titled "delayed perforation after endoscopic resection of a peutz-jeghers-type polyp arising from an inverted appendix." a 31-year-old man was referred for treatment of a cecal pedunculated (0-ip) polyp with a reddish, lobulated, and irregularly surfaced 40 mm head.The thick (10 mm) and long (20 mm) stalk originating from the appendiceal orifice was assumed to be an inverted appendix.After ligating the stalk in the lower third using an olympus endoloop, endoscopic resection was performed above the endoloop without any injection, forced coagulation.Wound closure was achieved using multiple endoclips.The patient was asymptomatic postoperatively, and blood tests on postoperative day one (pod1) showed no abnormalities; however, he developed fever and lower abdominal pain in the afternoon of pod1.Computed tomography revealed fluid retention in the abdomen, indicating delayed perforation.Because the abdominal pain was localized, conservative treatment was initiated with cefmetazole.Blood tests revealed a peak in white blood cells (10,200/mm2) on pod2 and c-reactive protein (23.0 mg/dl) on pod4.Computed tomography on pod6 revealed no additional leakage, and percutaneous drainage was performed for the intra-abdominal abscess.The patient started eating on pod11 and was discharged on pod21.The resected specimen showed a hollow stalk, suggesting full-thickness resection.In this case, the endoloop and endoclips might have dislocated when the inverted appendix returned to its original position after resection, resulting in delayed perforation.This literature article requires 1 report.There is no report of any olympus device malfunction in any procedure described in this study.

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 serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes information added to b5.Olympus will continue to monitor field performance for this device.

Event Description

A:though additional event details were requested by olympus, no further information was provided by the author.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18014949
• MDR Text Key: 326645096
• Report Number: 9614641-2023-01592
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• 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
• Treatment: ENDO CUT Q, ERBE ELEKTROMEDIZIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male