MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:370MM; CLIP APPLIER

Model Number PL536R

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that following a cholecystotomy procedure, the surgeon realized that the screw from the shaft of the clip applier (pl536r) was missing.It was determined the screw is retained in the patient's body.During the surgery, the clip applier displays issues; there was difficulty in re-setting of the clip.There was no delay in surgery was reported.No further patient hazard.No additional post-operative procedures performed to date, screw remains in patient.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the problem is most probably related to an insufficient maintenance of the device.Rational: based on the information available and our quality standards we exclude a material or manufacturer related error.No capa is necessary.

• Brand Name: SHAFT COMPL.D:10MM L:370MM
• Type of Device: CLIP APPLIER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5973655
• MDR Text Key: 55886893
• Report Number: 2916714-2016-00761
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL536R
• Device Catalogue Number: PL536R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/13/2016
• Date Manufacturer Received: 07/25/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other