MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HANDLE "HIQ+", ERGO, RATCHET; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	A60100A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that during three different therapeutic laparoscopic procedures the intestine of the patients was damaged.At the case at hand, the procedure was an anterior rectal resection.During the procedures several olympus instruments and devices from other manufacturers were used.It cannot be determined when and by which instrument the intestine was perforated.However, the perforation in the case at hand was detected two days after the initial procedure when the patient was subject to an additional surgery due to symptoms of peritonitis.According to the latest update all patients are well and there was no report about a product malfunction.
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's 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.
Additional Manufacturer Narrative
The suspect medical device and the concomitant medical products were returned to the manufacturer for evaluation/investigation.There were no reports of any malfunction of the medical devices used during the procedure.Apart from normal signs of wear due to frequent use and reprocessing, the investigation also did not reveal any anomalies, malfunctions or defects that may have caused or contributed to the reported event/incident.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.A material or quality problem can be excluded since a manufacturing and quality control review was performed for all affected serial/lot numbers of the medical devices used without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HANDLE "HIQ+", ERGO, RATCHET
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15040004
• Report Number: 9610773-2022-00278
• Device Sequence Number: 17878360
• Product Code: HET
• UDI-Device Identifier: 04042761009720
• UDI-Public: 04042761009720
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: A60100A
• Device Catalogue Number: A60100A
• Device Lot Number: 08XW-0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A LIST OF THE EQUIPMENT IN QUESTION IS ATTACHED; MEDTRONIC LIGASURE
• Patient Sex: Unknown