MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS "HIQ+", 5 X 430 MM, NEEDLE HOLDER, STRAIGHT; NEEDLE HOLDERS (HANDLES, JAWS INSERTS)

Model Number WA63708L

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to olympus 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 determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic total laparoscopic hysterectomy (tlh) procedure, the jaw of the needle holder broke off and fell inside the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided but the intended procedure was successfully completed and there was no report about an adverse event or patient injury.

• Brand Name: GRASPING FORCEPS "HIQ+", 5 X 430 MM, NEEDLE HOLDER, STRAIGHT
• Type of Device: NEEDLE HOLDERS (HANDLES, JAWS INSERTS)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 7360921
• MDR Text Key: 103551641
• Report Number: 9610773-2018-00026
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK944200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA63708L
• Device Catalogue Number: WA63708L
• Other Device ID Number: 04042761068772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2018
• 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: N
• Patient Sequence Number: 1