MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, MOUSE TOOTH, 7 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A4831

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/30/2021

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 therapeutic procedure the screw at the distal end of the grasping forceps detached and fell into the patient's uterine cavity.However, the screw was retrieved and the intended procedure was completed using another similar device.There was no report about an adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the cause of the reported event could not be conclusively determined.However, the reported issue was evaluated as plausible.However, since there is no screw at the distal end of the grasping forceps, it is presumed that, contrary to the customer's statement, a rivet and not a screw must have fallen into the patient during the procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the grasping forceps without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: GRASPING FORCEPS, MOUSE TOOTH, 7 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: 12768341
• MDR Text Key: 285394553
• Report Number: 9610773-2021-00316
• Device Sequence Number: 1
• Product Code: NWW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4831
• Device Catalogue Number: A4831
• Device Lot Number: 202W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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 Age: 26 YR
• Patient Sex: Female