MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A4825

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience 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 that during an unspecified uterus examination, when the surgeon removed the hysteroscope, he noticed that one jaw at the distal end of the grasping forceps was broken off and missing.He inserted the hysteroscope back into the uterus to check if the fragment was there but it could not be located.An x-ray examination was performed but the fragment still could not be located and it was assumed that it was flushed out with the irrigation fluid.The intended procedure was completed using the same set of equipment and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user¿s experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.A dhr review could not be performed since basic data of article identification (lot number) is missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.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: GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE
• Type of Device: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): DAUSCH MEDIZINTECHNIK GMBH; daimlerstrasse 13; wurmlingen
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12466026
• MDR Text Key: 271257110
• Report Number: 9610773-2021-00253
• Device Sequence Number: 1
• Product Code: NWW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4825
• Device Catalogue Number: A4825
• 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: 01/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female