MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP-TELESCOPE, 30, 4 MM CHANNEL; RIGID SCOPE

Model Number	WA33036A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.This event has been reported by the importer on mdr# (b)(4).
Event or Problem Description
The manufacturer received literature titled "interventional radiology-operated cholecystoscopy for the management of symptomatic cholelithiasis: approach, technical success, safety, and clinical outcomes".The objective of the study was to report the technique, complications, and clinical outcomes of interventional radiology¿operated cholecystoscopy with stone removal for the management of symptomatic cholelithiasis.Ten (77%) men and three (23%) women (mean age, 65 years) with symptomatic cholelithiasis underwent cholecystostomy followed by interventional radiology¿operated cholecystoscopy with stone removal.Major comorbidities precluding cholecystectomy included prior cardiac, pulmonary, or abdominal surgery; cirrhosis; sepsis with hyponatremia; seizure disorder; developmental delay; and cholecystoduodenal fistula.Cholecystostomy access, time between cholecystostomy and cholecystoscopy, endoscopic and fragmentation devices used, technical success, procedure time, fluoroscopy time, complications, length of hospital stay, time between cholecystoscopy and cholecystostomy removal, follow-up, and acute cholecystitis recurrence were recorded.The study concluded that interventional radiology¿operated cholecystoscopy may serve as an effective method for percutaneous gallstone removal in patients with multiple comorbidities precluding cholecystectomy.One patient developed acute pancreatitis four days after the procedure.The pancreatitis was managed medically but was complicated by an exacerbation of congestive heart failure.The patient was hospitalized for 32 days.Although requested, additional information could not be provided.
Additional Manufacturer Narrative
This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report.The complaint device was not returned to olympus for physical evaluation.No malfunction of the complaint device has been reported.It was not possible to perform a dhr review with a missing serial number.Instead, the manufacturing and quality control review was performed for the last 24 months of production and showed no non-conformities or deviations regarding the described issue.Based on the information provided, this complication, which occurred post-procedure, occurred as a result of the patient¿s condition prior to the procedure and could not be attributed to the procedure itself.

• Brand Name: OP-TELESCOPE, 30, 4 MM CHANNEL
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10390795
• Report Number: 9610773-2020-00186
• Device Sequence Number: 2814190
• Product Code: FGA
• UDI-Device Identifier: 04042761051866
• UDI-Public: 04042761051866
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: WA33036A
• Device Catalogue Number: WA33036A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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: Hospitalization; Life Threatening