MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, F. LITHOTRIPSY,

Model Number A20710A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.The grasping forceps was received with the jaws open and unable to close.There was no foreign material noted at the distal end of the device.The grasping forceps was received with both the inner sheath (a22040a) and the outer sheath (a22026a) attached.Mechanical testing was performed by manipulating the handle and noted looseness in the pulled and pushed motion.The jaws were unable to correspond due to the looseness of the handle.It is possible that the jaws guide wire is detached or broken.Visual inspection noted a screw on the black body of the locking cone was tampered with as there are indentations on the screw.The cause for the reported event cannot be determined at this time.The device will be sent to the oem for further investigation.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, the patient sustained an intraoperative injury as the forcep was removed in an open position.The surgeon observed bleeding and utilized cautery to treat the site.It was reported that while attempting to retrieve a stone the forcep became locked in an open position.The forcep was replaced and the intended procedure was completed.The patient was admitted to the hospital overnight for observation and was then discharged home.Additionally, it was reported that the patient returned to the facility for a routine post operative visit and is doing well.

Manufacturer Narrative

The oem's investigation confirmed that the grasping forceps are damaged and defective.A combination tests revealed that the forceps (a20710a) can, with opened/jammed jaws, be safely removed from the instrument combination ¿ consisting of resection sheath, outer sheath, with or without the adaptor, and also a cystoscope sheath.In this way, a safe change of instruments was also guaranteed for jammed forceps¿ jaws whilst the outer sheath or cystoscope sheath remained in the patient¿s body.The welded connection between the transmission-wire guide and the transmission wire, which functions as an overload protector, ruptured in order to prevent fracture of the hinge pin or similar damage to the forceps¿ jaws.The overload protector was properly activated as a consequence of intensive use combined with very high gripping forces.This can be detected by the indentations in the clevis slots.On the underside of the moveable jaw part, and in the connecting region of the transmission wire¿s hinge pin, clear traces of the application of mechanical force can be detected.The nature of this damage indicates that the jammed forceps was removed from the resection sheath or the cystoscope sheath using considerable force.With reference to the available information and photos, it may be concluded that the white insulation beak broke during the attempt to remove the jammed forceps from the resection sheath.The potential hazard for patients, which originated from this damage, could have probably been avoided if the resection sheath together with the jammed forceps had been removed together from the outer sheath.A potential safety risk for the patient can be eliminated since the forceps¿ overload protector was properly activated in order to prevent fracture to the hinge pin or similar damage in the forceps¿ jaws.The requirement, as formulated in the product standard ¿no parts are to fall into the body¿, is met with the function of the welded connection between the transmission-wire guide and the transmission wire as an overload protector.The optical forceps a20710a are not designed to crush large stones but rather as grasping forceps.To crush stones, the bladder stone forceps are available.As a consequence of inappropriate use, e.G.Crushing bladder stones by applying considerable forces, it is possible that following activation of the overload protector, the forceps¿ jaws becomes jammed open and cannot be completely closed.In addition, a material or quality problem can be excluded as a manufacturing and quality control review was performed for the affected lot number 164w-0024 of the a20710a grasping forceps without showing any abnormalities related to function and safety.The root cause is attributed to applied excessive force / mechanical overload.

• Brand Name: GRASPING FORCEPS, OPTICAL, F. LITHOTRIPSY,
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6122644
• MDR Text Key: 60745037
• Report Number: 2951238-2016-00882
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: A20710A
• Device Lot Number: 34W-0002
• Other Device ID Number: 04042761019989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: A20710A, LOT# 164W-0024; A22040A, LOT# 34W-0076
• Patient Outcome(s): Hospitalization; Required Intervention