MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GRASPING FORCEPS

Model Number	FG-32C-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's 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 or Problem Description
It is reported in the literature titled "endoluminal appendectomy: the first description in humans for acute appendicitis", a patient experienced abdominal pain and low grade fever on the first post-operative day requiring medical intervention.In this case study, a (b)(6) year-old male presented with vague lower abdominal pain and fever.Two days earlier, an ultra sonography showed an enlarged appendix.A colonoscopy was performed to investigate synchronic lesions and showed only a purulent discharge from the appendiceal orifice.Pathological assessment confirmed acute appendicitis.The authors described the first procedure to remove the appendix using colonoscopy during acute appendicitis presentation using a handmade double channel colonoscope prototype with an adapted 20 fr nasogastric tube, along with olympus shark tooth grasping forceps, endoclips, and endoloop and a boston scientific standard diathermic snare wire loop.The patient experienced abdominal discomfort and low-grade fever on the first postoperative day.He received ceftriaxone 2 g/day and metronidazole 1.5 g/day for 2 days; oral diet was started on the same day.On the second postoperative day, the patient¿s condition improved, without any report of pain.
Additional Manufacturer Narrative
This report is being updated to report investigation findings.The device history record (dhr) for the complaint device could not be reviewed as the serial number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.The definitive cause of the reported event could not be established.There was no report of device malfunction.

• Brand Name: GRASPING FORCEPS
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11930305
• Report Number: 8010047-2021-07057
• Device Sequence Number: 3098695
• Product Code: EOQ
• UDI-Device Identifier: 04953170032165
• UDI-Public: 04953170032165
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K962533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG-32C-1
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR