SCISSORS, 5 FR., SEMIFLEXIBLE A4826

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-07 for SCISSORS, 5 FR., SEMIFLEXIBLE A4826 manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[132204321] 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.
Patient Sequence No: 1, Text Type: N, H10


[132204322] Olympus was informed that during a therapeutic laparoscopic cholecystectomy procedure at an unknown date, the patient sustained a perforation of the bowel. The intended procedure was converted to open surgery where the perforation was treated. The patient was subsequently hospitalized for recovery for three days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610773-2019-00040
MDR Report Key8221492
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-01-07
Date of Report2019-01-07
Date Mfgr Received2018-12-28
Date Added to Maude2019-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL WLADOW
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal22045
Manufacturer Phone4940669662
Manufacturer G1DAUSCH MEDIZINTECHNIK GMBH
Manufacturer StreetDAIMLERSTRASSE 13
Manufacturer CityWURMLINGEN 78573
Manufacturer CountryGM
Manufacturer Postal Code78573
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCISSORS, 5 FR., SEMIFLEXIBLE
Generic NameHAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
Product CodeLRW
Date Received2019-01-07
Model NumberA4826
Catalog NumberA4826
Lot Number814806
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-01-07

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