MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number A22026A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patients' outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed about the literature study ¿outcomes of surgical hysteroscopy: 25 years of observational study¿.The aim of this study was to analyse the complications arising from operative hysteroscopies performed during the last 25 years at hospital parc taulí de sabadell and to describe their differences according to the type of procedure performed.3.063 operative hysteroscopies were performed, 52.7% were polypectomies and 31.5% were myomectomies.Myectomies had the highest incidence of complications, at 14%, followed by septolysis, at 6.9%.The most common complications were mechanical (52%).Myomectomies had seven times higher risk than polypectomies of distension-medium complications but three times lower risk of mechanical complication.The highest incidence of complications occurred in type i myomas and those larger than 3 cm.If study defines fluid-balance complications as only those patients who absorbed more than 1.5 l and developed related symptoms, overall complication rate, including all mechanical complications, was 5.6%.The type of adverse events occurred during the study at hand are cervical tear, uterine perforation, false cervical route, vaginal tear, false endometrial route, hemorrhage, hyponatremia, electrical complications as well as anesthesia complications.The study indicates that the mechanical injuries of before mentioned adverse events were produced with different instruments, the hysteroscope itself (24%).11 patients required surgery to treat their complication.However, throughout the study report there was no report of a malfunction of any of the olympus medical devices.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation.Since no malfunction of an olympus medical device was reported, the suspect medical device is assumed to meet its specification.However, the exact cause of the patients' outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (serial number) are missing.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
• Type of Device: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15614183
• MDR Text Key: 301822153
• Report Number: 9610773-2022-00477
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761029346
• UDI-Public: 04042761029346
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A22026A
• Device Catalogue Number: A22026A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OLYMPUS ELECTROSURGICAL UNIT (UES-40).; OLYMPUS TELESCOPE 12° (A22001A).; W.O.M. BALANCING SYSTEM "HYSTEROBALANCE" (A40602A).; W.O.M. PUMP "HYSTEROFLOW" (A40601A).
• Patient Outcome(s): Required Intervention
• Patient Sex: Female